Clinical Research Directory

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)

IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes

The goal of this observational study is to better understand how the pancreas works in adults with type 2 diabetes. The study focuses on both hormone production (endocrine function) and digestive function (exocrine function) of the pancreas. The main questions it aims to answer are: * Can problems with the pancreas help identify a different type of diabetes called pancreatogenic diabetes? * How are blood markers and pancreas structure related to pancreatic function? Participants will: * Have blood tests to measure glucose, insulin, and other markers * Provide a stool sample to assess digestive function * Undergo an ultrasound examination of the pancreas * Answer questions about digestive symptoms The study will take place during a single visit in outpatient clinics.

The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes

To evaluate the effects of subcutaneous injection of semaglutide for 12 weeks on patients with type 2 diabetes mellitus (T2DM), compared with concurrent energy-restricted management, on glycemic control, weight loss, inflammatory markers, liver fat content, and other parameters. The study also observed the subcutaneous and visceral fat of the participants and explored the molecular mechanisms of action, providing high-quality evidence-based support for the timing and targets of intervention in this population.

A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM

The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 * evaluate the efficacy, safety, tolerability, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia

This study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45\~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance, metabolic control, and quality of life.

The Laparoscopic Transit Bipartition With Use Metalic Anastomosis Clip

This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg/m²). Currently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg/m². However, many T2DM patients fall below this threshold and cannot access surgical treatment under existing guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation. The MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs. Participants will be randomised into three groups: MAC-assisted anastomosis, hand-sewn anastomosis, or stapled anastomosis. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.

Diabetes Management for Primary Healthcare Centers.

The purpose of this study, "Integrating diabetes care into Primary Healthcare Centers (PHCs) in Abuja, Nigeria: a pilot study," is to screen, diagnose, treat, and educate diabetes patients in two selected PHCs in Abuja. This single-arm pilot trial will test the feasibility of integrated diabetes care, measure the implementation outcomes, and explore the effectiveness of the strategy bundle using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

A Telenursing Program to Support Diabetes Self-Management

This randomized controlled trial aims to develop and evaluate a telenursing-based Diabetes Self-Management Education and Support (DSMES) program with uncontrolled type 2 diabetes mellitus in Thailand. The program is designed to improve diabetes self-management through nurse-led education, behavioral support, and regular follow-up delivered via telecommunication technologies. Participants with type 2 diabetes and poor glycemic control will be randomly assigned to either an intervention group receiving a 12-week telenursing DSMES program or a control group receiving usual care. The intervention includes an initial in-person education session followed by structured video call follow-ups provided by nurse. The primary outcome of this study is the feasibility of implementing telenursing for DSMES in Thailand. Secondary outcomes include changes in glycemic control, body mass index, diabetes knowledge, self-care behaviors, coping behaviors, quality of life, healthcare costs, and frequency of acute care use. The findings from this study are expected to provide evidence to support the use of telenursing as an accessible and sustainable approach for diabetes self-management in the Thai healthcare context.

Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes

People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. The DASH-Life research study will recruit adults with hypertension and type 2 diabetes who live in Baltimore metro areas that don't have many stores selling healthy foods. The DASH-Life research study is 6 months long. Participants will be randomly assigned to one of two groups: 1) Self-Shopping DASH (S-DASH) diet advice group, or 2) Coaching DASH (C-DASH) diet advice group.

Polyphenol Metabotypes in People With Diabetes Type 2

This cross-sectional study seeks to characterize the overall polyphenol metabotype in patients with T2DM in comparison to age-matched individuals without diabetes. Additionally, the study aims to identify factors that influence the polyphenol metabotype (transit time and gut microbial capacity to degrade polyphenols in particular).

Feasibility of a Tailored Online Self-compassion Intervention

The goal of this clinical trial is to examine the feasibility and acceptability of an online programme that is based on Compassionate Mind Training (CMT) over four-weeks. The programme intends to share information and strategies to reduce diabetes distress, self-criticism, and shame, and improve physical health in people who have Type 1 and Type 2 Diabetes Mellitus.

Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes

The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.

MRI Assessment of Pancreatic Fat Changes and Islet Function Recovery After Bariatric Surgery in Obese Patients

This study evaluates changes in pancreatic fat and recovery of pancreatic function in obese patients undergoing laparoscopic sleeve gastrectomy (LSG), a weight-loss surgery. Obesity can cause fat to accumulate in the pancreas, which may impair insulin production and lead to type 2 diabetes. This study uses magnetic resonance imaging (MRI) to measure pancreatic fat before and after surgery to understand how weight loss affects pancreatic function. About 50 obese patients (BMI \> 32 kg/m²) aged 16-60 years who are scheduled for LSG will be enrolled. Participants will undergo MRI scans of the pancreas and blood tests before surgery and at 1, 3, and 6 months after surgery. The MRI uses a safe, non-invasive technique called Dixon imaging to measure fat content in different parts of the pancreas (head, body, and tail). Blood tests will measure fasting glucose, insulin, C-peptide, and HbA1c to assess pancreatic function. The study aims to determine whether reduction in pancreatic fat after weight-loss surgery is associated with improved insulin secretion and reduced insulin resistance. This information may help doctors better understand how bariatric surgery improves metabolic health and guide postoperative patient management. Participation involves no additional risk beyond routine clinical care. All MRI scans and blood tests are part of standard postoperative monitoring for bariatric surgery patients.

A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM

Integrating New Skills Into Diabetes Education With CGM

This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program ("intervention") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches ("comparators"). Following a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator A) will receive a one-time clinic-based CGM training. The second comparator (Comparator B) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks. The study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. Lastly, an extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.

Investigation of Motor Imagery Ability, Body Awareness and Cognitive Functions in Type 2 Diabetes Mellitus

The aim of this study is to examine the relationship between motor imagery skills, body awareness and cognitive functions in individuals with Type 2 Diabetes mellitus.

Achieving Routine Intervention and Screening for Emotional Health

The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).

Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

This study aims to improve patient awareness of the utility of continuous glucose monitoring systems in blood glucose monitoring and to improve patient satisfaction regarding diabetes care, particularly in the matter of blood glucose monitoring, at the transitions of care from the inpatient setting to the ambulatory setting.

Glycemic Variability of Combination Therapies in T2DM

Glycemic Variability of Combination Therapies in T2DM

Human Immunodeficiency Virus (HIV) Food Insecurities

The objectives of this study are to better understand how FI (food insecurities) contributes to the development of cardiometabolic comorbidities among PWH (People with HIV) and to test a novel bilingual FI intervention designed to reduce these comorbidities among food insecure PWH. The PI and staff will conduct this study in partnership with the Wake Forest Infectious Diseases Specialty Clinic, one of the largest Ryan White-funded clinics in North Carolina, which serves more than 2,000 PWH annually from a predominantly rural catchment area that includes South Central Appalachia. This area has high rates of both FI and HIV.

The Effect of Local Corticosteroid Injection in Carpal Tunnel Syndrome Patients With Type 2 Diabetes

Our study was planned as a prospective observational study aiming to compare the post-intervention recovery process between patients with carpal tunnel syndrome (CTS) and diabetes mellitus and patients with idiopathic carpal tunnel syndrome without diabetes mellitus. Patients who presented to the Physical Medicine and Rehabilitation outpatient clinic with clinical symptoms consistent with carpal tunnel syndrome and who were diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological findings and who received corticosteroid + local anesthetic injection will be included in the study. Data from patients who meet the inclusion and exclusion criteria will be included in the study. Patients' demographic and clinical data will be recorded. Records will be taken before treatment and at 4 and 12 weeks after treatment.

MagDI Italian Study

The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).

Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes

This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule. Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2. The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction. This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.