Clinical Research Directory

Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV

This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.

Development of an Inclusive Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial

This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.

How Metabolism Affects Weight Loss and Gain

This study examines why some individuals with obesity have difficulty losing weight, whereas some lean individuals struggle to gain weight. The investigators will measure how the human body uses energy during a fasting period and after consumption of a specially designed, low-protein meal. By comparing these responses, the investigators aim to identify different "metabolic phenotypes" that affect weight control. Findings from this research may lead to more personalized treatments for managing weight. Participation in this study involves simple tests and basic body measurements.

Metabolic Phenotyping for Personalized Obesity Therapy

This study aims to develop a simple, clinically applicable method for metabolic phenotyping to personalize obesity therapy in morbidly obese individuals. The underlying concept is that the way a person's resting metabolic rate (RMR) responds to a 24-hour fast can help distinguish between two metabolic phenotypes. Individuals with a "thrifty" metabolism show a significant drop in RMR during fasting, which may make them less responsive to conventional weight loss interventions. In contrast, those with a "spendthrift" metabolism exhibit little to no drop-or even a slight increase-in RMR, suggesting they may lose weight more readily. The trial is designed as a prospective, single-center, longitudinal cohort study involving 20 morbidly obese patients (BMI \>40 kg/m²) who are already participating in a multimodal obesity therapy program. The study is divided into three phases. In the baseline phase, participants undergo comprehensive screening, which includes physical examinations, blood tests, and body composition assessments. RMR is measured using indirect calorimetry both before and after a 24-hour fasting period, and a device (Lumen™) is used to assess whether the body is primarily burning carbohydrates or fats. After the fasting measurements, participants perform a low-protein meal test by consuming a specially calibrated chocolate beverage. Their RMR is then monitored at several time points to determine the energy required for digestion. Following this, the study moves into the very-low-calorie diet (VLCD) phase, where participants consume approximately 800 kcal per day using formula meals tailored to meet their nutritional needs despite the calorie restriction. During this 12-week phase, changes in body weight, composition, and metabolic parameters are closely monitored. The final phase of the study is a 12-week weight maintenance period, during which the focus is on sustaining the achieved weight loss. In addition to RMR and dietary assessments, advanced techniques such as metabolomics are employed. Blood, urine, and saliva samples are collected to analyze metabolic profiles and identify potential hormonal biomarkers-such as leptin, FGF21, and adrenaline-that could further differentiate the "thrifty" and "spendthrift" phenotypes. Body composition is also assessed using methods like bioimpedance analysis (BIA), quantitative magnetic resonance imaging (qMR), and air displacement plethysmography (BodPod). By correlating the changes in RMR with metabolic and hormonal markers, the study tests the hypothesis that individuals with a marked RMR decrease during fasting (the "thrifty" phenotype) may experience less weight loss during a hypocaloric diet compared to those with minimal RMR change (the "spendthrift" phenotype). If validated, this approach could allow clinicians to predict weight loss outcomes more accurately and tailor obesity treatments to the individual's unique metabolic profile.

Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.

The Efficacy and Safety of Herbal Medicine Treatment for Obese Patients With Spinal and Joint Pain

This study is a pragmatic pilot randomized controlled trial aimed at investigating the effectiveness of herbal medicine treatment for obese patients with spinal and joint pain, using a control group receiving lifestyle guidance.

Meal Frequency and Timing on Metabolic Health in Patients With Type 2 Diabetes

The goal of this clinical trial is to learn if changing when and how often people eat works to improve health in adults with Type 2 diabetes. The main questions it aims to answer are: How do these eating patterns change body weight and body fat? Does changing meal timing and frequency lower blood sugar levels (HbA1c) over 12 weeks? Does it lower blood fat levels, such as cholesterol and triglycerides? Researchers will compare three groups to see which eating pattern works best: Standard Group: Participants eat 3 main meals and 3 snacks (6 times total) each day with a calorie limit. 3-Meal Group: Participants eat only 3 main meals each day with a calorie limit. Time-Restricted Group: Participants eat all their daily food within an 8-hour window (from 12:00 to 20:00) without a calorie limit. Participants will: Follow their assigned eating plan for 12 weeks. Visit the clinic once every month for checkups and body measurements. Give blood samples at the start and end of the study for laboratory tests. Record the food they eat and their physical activity levels.

Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer

This is a feasibility study that will collect data to assess the potential effect of nutritional intervention. This prospective single-site trial will enroll adult patients with liver diseases such as metabolic-dysfunction associated steatotic liver disease (MASLD), metabolic-dysfunction associated steatohepatitis (MASH), cirrhosis and/or hepatocellular carcinoma (HCC). Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating plus targeted healthy changes in what they eat (TR-HE). The intervention includes dietary counseling visits with a study registered dietitian (RD) and motivational phone calls with a study Certified Health and Wellness Coach (HC). Individuals who are randomized to the control group or who elect to join the control group will be enrolled in a six-month period of observation and phlebotomy only. The main questions it aims to answer are: Is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver disease or cancer? Does the intervention improve liver metabolism?

Evaluation of Anterior Neck Ultrasound in Predicting Difficult Airway in Obese Patients

Obese patients are at increased risk of difficult airway management due to anatomical changes in the anterior neck soft tissues. Accurate preoperative prediction of difficult airway remains challenging using conventional clinical airway assessment tests alone. This prospective observational study aims to evaluate the role of ultrasound assessment of anterior neck soft tissue thickness in predicting difficult airway risk in overweight and obese adult patients undergoing elective surgery under general anesthesia. Ultrasound-based anterior neck measurements will be compared with standard clinical airway assessment parameters to determine their diagnostic accuracy for difficult laryngoscopy and intubation. The results of this study may contribute to improved preoperative airway risk stratification and safer airway management in obese patients.

The Causal Role of Ketone Bodies in Obesity-associated Disease Prevention - Combining Genetic Epidemiology With a Randomised Trial to Infer Causality

Excess weight increases the risk of several diseases including cardiovascular disease, type 2 diabetes, kidney disease and various cancers. There is a need for preventative strategies for obesity-associated disease, especially for people in the overweight and moderately obese ranges where pharmacological intervention may not be suitable. Low-carbohydrate (ketogenic) diets are popular for weight control. Ketogenic diets increase circulating ketones, which can have favourable effects on cardiometabolic health markers. However, the ketogenic diet has a nutrient composition associated with harms (high-saturated fat/red meat, and low-fibre). The net effects of ketogenic diets on long-term health are unclear. Ketone supplements can increase circulating ketones and could provide benefits of ketosis without needing to adhere to a potentially harmful diet. Establishing causality between complex exposures (e.g., diet) and long-term outcomes (e.g., disease), is challenging. The MRC \& NIHR Review of Nutrition and Human Health Research (2017) highlighted an "overreliance (as opposed to reasonable reliance) on observational studies" as a key barrier to progression in the field of nutrition and health. Randomised controlled trials (RCTs) facilitate causal inference, but for long-term outcomes are expensive, time-consuming, and often suffer from waning adherence. Mendelian randomization (MR) can estimate causal effects subject to key assumptions. A challenge to these assumptions includes complex behavioural exposures (e.g., diet), which could be intercorrelated with causal factors. Our proposal will address these limitations with a novel combination of study designs to establish causal effects of ketosis (via diet and supplementation) on obesity-associated disease risk in humans. The investigators will combine a tightly controlled, short-term RCT, with MR to link short-term responses to long-term endpoints. The investigators will examine the circulating (blood) and tissue-specific (adipose) transcriptomic and proteomic responses in the fasted and postprandial state in response to our dietary interventions and translate these to MR by identifying single-nucleotide polymorphisms from genome wide association studies. This approach overcomes limitations of RCTs and MR, as adherence to diets will be confirmed with controlled feeding, and intermediate molecular traits as exposure for MR are less likely to be intercorrelated with causal traits.

Different Efficacy of IFA Supplementation Among Obese and Non-obese Women

This clinical trial aims to learn if there is a relationship between OWT/OB and IDA in nonpregnant women of reproductive age and its impact on iron supplementation. The main questions it aims to answer are: * Is there any independent association between overweight/obesity and iron deficiency anemia in nonpregnant women after controlling for potential confounding factors? * Does the effect of iron supplementation on iron status vary between overweight/obese and normal-weight nonpregnant women (as measured by multiple iron biomarkers)? Researchers will compare several biomarkers between the case and control groups after the intervention is given for 90 days. Participants will: * Visit the research center before the intervention given and after 90 days * Take daily iron-folic acid supplements for 90 days * Keep a diary of their supplement's intake

Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery

This study aims to identify pre-operative phenotypic determinants predictive of quality of life trajectories in post-bariatric surgery patients. In addition, this study will have as a secondary objective the highlighting of a potential link between post-surgery quality of life trajectories and those of anxiety/depression scores, eating behaviors and body mass indices. This study will be conducted during the usual care of patients undergoing the GEROM73 program, lasting a total of 30 months. The GEROM73 program includes care for the six months preceding bariatric surgery and the 24 months following surgery. This program supports patients throughout their bariatric care.. Throughout the GEROM73 program, patients will complete questionnaires on anxiety, depression, eating disorders, Impact of Weight on Quality Of Life. Patients' weight, body mass index and body schema will also be measured throughout the GEROM program.

EXploratory Study on Postprandial Energy Metabolism

This exploratory, double-blinded clinical trial on 66 randomized adults aged 50 to 70 years with moderate overweight or obesity but considered metabolically healthy will consist of comparing metabolic and microbiota parameters before and after 3 months of consumption of a probiotic or a placebo.

A Study of MET233 in Individuals With Obesity or Overweight

The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 in otherwise healthy adults with overweight or obesity. This study will be conducted in four parts: * Part A will evaluate single ascending doses of MET233 or placebo. * Part B will evaluate multiple ascending doses, with participants receiving five once-weekly doses of MET233 or placebo. * Part C will evaluate once-weekly dosing of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose. * Part D will evaluate a longer dosing schedule, in which participants will receive twelve once-weekly doses, followed by three monthly doses of MET233 or placebo. Participants in this part will be followed for 14 weeks after the final dose.

Advancing Biopsychosocial Care Training Initiative

This project will compare two training approaches for US Preventive Services Task Force recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims. Aim 1 compares patient-level effectiveness \[i.e., patient relative weight change and the proportion of patients who achieve clinically significant weight loss\]. Aim 2 compares reach (patient treatment utilization). Aim 3 compares primary care provider (PCP) referrals to USPSTF-recommended care at 12 (adoption) and 24 months (maintenance) and short- and long-term changes in provider obesity care competencies . Aim 4 compares implementation and service costs.

The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Weight Loss in Overweight and Obese Patients

This doctoral dissertation takes into account epidemiological and clinical data of the international literature about obesity and, generally, increased body weight (BMI≥ 25kg/m2) and their consequences on health. Obesity management challenges many specialties, while, currently, the approved therapeutic methods are dietary intervention, various drugs and, in severe cases, bariatric surgery. All of the above methods show some degree of recurrence, while surgery carries the risk of serious complications. Repetitive transcranial magnetic stimulation (rTMS) is classified into non-invasive brain stimulation methods and utilizes magnetic pulses generated by a coil to bring about changes in the brain. The method has already been approved for the treatment of some disorders, while it seems to help in the fight against many more psychiatric and neurological, mainly, diseases. The aim of the research will be to investigate the effectiveness of TMS in reducing body weight in participants with BMI≥ 25kg/m2. The doctoral dissertation will study the reduction of BMI in obese and overweight patients and the variation of this reduction depending on the severity of obesity and age. In addition, it will investigate the effectiveness by setting as a parameter the observance of a diet. It will also record and statistically process the improvement of symptoms in the spectrum of some psychiatric disorders (eg depressive and psychotic symptoms, psychosomatic disorders). The participants in the research will be hospitalized patients of the Psychiatric Clinic of the University General Hospital of Larissa (PGNL) and citizens. Clearly, patients from other clinics or other citizens can also participate in the research, provided they have a BMI≥ 25kg/m2. They will undergo 20 rTMS sessions (4 per week, for 5 weeks) and an assessment of BMI and some psychiatric symptoms before the start, at the end, 4 weeks after and 6 months after the end of the sessions. The rTMS will be applied to the left dorsal prefrontal cortex (left DLPFC), with an 8-coil in the following conditions: frequency 10 Hz, 75 4-second trains with 26-second intertrain interval, at 120% of the threshold for motor cortex activation. Participants will be divided into three groups: those who will not receive TMS, those who will receive sham TMS and those who will receive active TMS. These patients will then be compared with each other to answer the research questions. The therapeutic protocol presented is based on the international literature, while it presents positive results in the studies in which it has been applied. Prerequisites for participation in the study are patient consent and BMI≥ 25kg/m2. In order to receive TMS, the patient first needs to agree and clarify that he / she does not have an individual or family history of seizures and that he / she does not have a cochlear implant. If the patient wishes, he can withdraw from the study at any stage. In addition to seizures, other side effects of treatment include headache and hearing loss (for which the patient will use earplugs). The present dissertation will contribute to the further understanding of the mechanisms of obesity as well as the development of new therapies for the treatment of the disease.

Impact of Chia Seeds on Human Breast Milk Composition

The investigators' over-arching hypothesis is that mechanical and compositional properties of chia seeds supplemented during lactation diminish obesity-induced intestinal inflammation and barrier dysfunction. The investigators hypothesize these changes will result in: 1) reduced maternal systemic inflammation (serum CRP and IL-6) and increased gut microbial diversity and richness, 2) reduced HM fat and inflammatory markers, metrics the research team have demonstrated differ in tandem with maternal metabolic health and 3) improved infant growth/body composition. To test these hypotheses, investigators will evaluate chia seed supplementation during lactation in a 6wk multi-site pilot RCT (Aim 1) and through translational studies using human enteroids (Aim 2).

Effect of Aqueous Extracts of Cissus Quadrangularis and Dichrostachys Glomerata on GLP-1 Concentration and DPP-4 Activity in Overweight and Obese Adults

Obesity is a global health crisis affecting over 2.3 billion individuals worldwide. This prospective study aims to evaluate the comparative effects of standardised Cissus quadrangularis extract (CQE) and Dichrostachys glomerata extract (DGE) on obesity-related parameters, focusing on their impact on glucagon-like peptide-1 (GLP-1) levels and dipeptidyl peptidase-4 (DPP-4) enzyme activity in obese subjects. Parameters such as GLP-1 levels, DPP-4 activity, food intake, satiety, body weight, blood lipids, fasting blood glucose, and visceral fat mass will be measured at baseline and various intervals. In our previous pre-clinical trial involving 18 adult male Wistar rats (150-200 g), randomly divided into three groups: a control group fed a normal diet, and two treatment groups receiving DGE (400 mg/kg) or CQE (300 mg/kg) alongside a normal diet, the results demonstrated that both DGE and CQE significantly increased GLP-1 levels and inhibited DPP-4 activity compared to the control group. These effects were associated with reduced food intake, body weight, and fasting blood glucose levels. Additionally, both extracts positively modified blood lipid profiles, with significant changes in HDL, LDL, and triglyceride levels. The findings suggest that DGE and CQE exert their anti-obesity effects through mechanisms involving GLP-1 enhancement and DPP-4 inhibition, offering potential therapeutic pathways for weight management and metabolic health. This prospective study aims to provide clinical evidence supporting the use of these plant extracts in addressing obesity and its related complications.

Study of Patients Being Treated With Anti-obesity Medication

The goal of this observational study is to learn about the real-world effects of selected obesity medications in adults undergoing medical weight management. The main outcomes of interest are changes in body composition, routine clinical markers, muscular performance, and nutritional intake over the course of treatment. Additionally, the influence of lifestyle factors on changes in these outcome variables will be examined. Participants beginning treatment with selected obesity medications will undergo periodic body composition and muscular performance testing, as well as complete online surveys about their nutritional intake and physical activity and exercise participation. Additionally, routinely collected clinical information will be evaluated.

Metabolic Health, Bones and Nuts During Weight Loss in Adults

The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. In addition, our preliminary translational data indicates that a higher monounsaturated fatty acid (MUFA) intake is associated with improved bone mineral density (BMD) and quality. Given these findings, the proposed study aims to examine the impact of consuming peanut products on bone health, metabolic health (e.g., serum glucose, insulin, lipids and inflammation), markers of brain and sleep health, and physical function in overweight and obese older adults before and after a six-month weight loss intervention using a randomized controlled design. The results of this study have the potential to provide valuable insights into the role of peanuts as a sources of fatty acids in promoting health and preventing disease in at-risk adults.

Adaptation of Human Brown Adipose Tissue to Calorie Restriction

The BATON study investigates how human brown adipose tissue (BAT) adapts to a controlled caloric restriction diet in young adults with obesity. A weight maintenance diet group will be compared to a group following a diet designed to induce an 8-10% weight loss over a 12-16 week period. Outcome assessments will include advanced technologies such as PET-CT and molecular analyses of BAT. The overarching goal is to gain a deeper understanding of the role of human BAT on the regulation of body weight.

Muscle and Movement With Anti-Obesity Medications

The goal of this clinical trial is to learn about changes in body composition related to obesity medication use, and whether aerobic or resistance exercise training will impact these body composition changes. It will also provide information about whether aerobic or resistance exercise training has additional benefits on other health and fitness measurements. The main questions it aims to answer are: * Is there a difference in the change in body composition (fat mass, lean mass, muscle mass, and bone content) between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in body weight and BMI between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in cardiorespiratory fitness between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in how much physical activity is completed between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in physical function between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in muscle strength between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in resting blood pressure between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in food intake between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in health-related quality of life between the standard medical care and the exercise conditions (aerobic training and resistance training)? Participants will: * Participate in an intervention for a period of 6 months that involves being assigned to a no exercise/standard medical care condition, or a supervised exercise condition (aerobic training or resistance training). * Visit the clinical before starting the study and at 6 months to complete study measurements of their body composition and other measurements to monitor their progress. * Complete a brief monitoring session at weeks 6, 12, and 18 across the 6 months. * Complete supervised exercise sessions at the research center 3x per week for 6 months (Participants in the exercise groups only: aerobic training or resistance training).

Brain and Behavior Influences on Obesity Development From Infancy Through Childhood

The investigators project, RESONATE, aims to investigate why some children develop obesity. To do this it uses data on eating and eating-related behaviors, genetic and environmental factors, and brain structure and function. This data is collected in a sub-sample of RESONANCE, a large study of families of children from infancy through childhood. The results will lay foundations for the development of early interventions to prevent or treat obesity.

Palmitic Acid and Human Microvascular Function

The goal of this study is to learn how a supplement Quercetin can affect microvascular function. Participants will: * give two blood draws of 5 mL each * have a camera placed under the tongue to take pictures of blood vessels * have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.