Clinical Research Directory

Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality

Primary objective: To evaluate the effectiveness of the ARISE strategy on the proportion of individuals with confirmed T2DM diagnosis, per protocol criteria based on the PCDT-DM2 (Clinical Protocol and Therapeutic Guidelines for T2DM), among adults eligible for screening registered at UBS (Primary Health Care Units) in Afogados da Ingazeira, during the 12 months post-implementation, compared to a reference value estimated from a historical 12-month period in the same municipality. Methodology: Pragmatic, quasi-experimental, single-arm effectiveness and implementation study with a historical comparator. In each period, the analytic population will be defined by eligibility on the respective index date. In the historical period, data will estimate the reference proportion of the primary outcome and historical values of applicable secondary outcomes. In the post-intervention period, individuals eligible on the index date will be followed for 12 months via care records. Individuals who become eligible after the post-intervention index date may receive care actions under the strategy and be included in operational, implementation, and exploratory analyses, but not in outcome denominators fixed at the index date. The study will take place in Afogados da Ingazeira, Pernambuco, covering all 15 UBS with an affiliated Family Health Team. Research-specific technological components will incur no additional cost to the municipality. ARISE comprises two components: 1. Digital analytics layer, built on the existing epHealth infrastructure. It uses structured data from e-SUS PEC to apply predefined T2DM screening eligibility rules. Identified individuals appear in operational lists and may generate alerts for UBS managers and community health workers, supporting visits, scheduling, test requests, follow-up, and patient return. It may also flag: delays over 60 days between test request and completion, availability of lab results, and need for active case-finding. No test, diagnosis, prescription, referral, or treatment is automated; clinical decisions remain with APS professionals and managers. 2. Professional training. UBS managers, community health workers, physicians, nurses, and nursing technicians will be trained on the PCDT-DM2 and ARISE workflows, before the digital layer's activation. Professionals are research participants only for evaluating educational impact, acceptability, and usability, provided they attend the relevant training and sign the Informed Consent Form (ICF). Training participation is independent of research participation; declining data use carries no functional or institutional penalty. A census-based approach will define population size. The primary analysis includes all individuals eligible on the post-intervention index date; final numbers depend on municipal database findings. Power calculations covered 8,000-30,000 eligible individuals and historical T2DM diagnosis proportions of 0.80%-0.90%. A population of \~14,000-15,000 eligible individuals yields \~80% power to detect a \~25% relative increase, for historical proportions of 0.85%-0.90%. For professional-related components, a census approach covers all eligible categories per the updated roster of active professionals directly involved. Statistical analysis: The post-intervention proportion of confirmed T2DM diagnosis will be compared to the historical reference using a two-tailed one-proportion test (5% significance level). Point estimates, 95% CIs, absolute differences, and proportion ratios (where applicable) will be reported. Adjusted analyses may use logistic regression. Change in professionals' knowledge will be analyzed via paired intra-individual pre/post-training score differences. RE-AIM indicators will be mainly descriptive. Acceptability, training reaction, and workflow perception blocks will be scored separately (1-5). Usability will be assessed via the System Usability Scale (0-100) among professionals who directly used the digital component. The study was approved by the Research Ethics Committee (REC), CAAE n. 00260026.5.0000.5330, approval opinion n. 8.705.723. Primary outcome: Confirmed T2DM diagnosis during the observation period, treated as a binary individual indicator.

Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy

This study aims to determine the effect of the 4-7-8 breathing technique, applied during Electromyography (EMG) for the diagnosis of diabetic peripheral neuropathy, on the pain and anxiety levels experienced by patients with Type 2 diabetes. EMG is a diagnostic method that can cause pain and anxiety in patients. Due to the limited number of non-pharmacological studies in the literature focusing on pain management in diabetic individuals during this process, the investigation of the effectiveness of the 4-7-8 breathing technique, which strengthens parasympathetic activity, using a randomized controlled design constitutes the unique value of this study. The research will be conducted in a randomized controlled experimental design. The sample will consist of individuals diagnosed with Type 2 diabetes who are referred to the EMG outpatient clinic of Osmaniye Training and Research Hospital. The experimental group will receive training on the 4-7-8 breathing technique and will be instructed to apply it during the procedure, while the control group will receive the routine clinical protocol. Data will be collected using the Patient Identification Form, Numerical Rating Scale (NRS), State Anxiety Scale (SAS), and Neuropathic Pain Questionnaire (DN4). The study expects the 4-7-8 breathing technique to significantly reduce pain and anxiety levels. It aims to improve the comfort of diabetic patients during procedures and the quality of diagnostic data, and to introduce this method into the literature as a low-cost and independent pain management strategy in nursing care. Furthermore, the study aligns with the "Health and Quality of Life" (SDG3) goal, which is part of the Sustainable Development Goals set by the United Nations. SDG3 offers a comprehensive global framework aimed at ensuring healthy living for all individuals and promoting well-being at all ages; it includes increasing access to health services, improving the quality of care, and strengthening patient-centered approaches.

Effect of Type 2 Diabetes on Biomarker Levels in Albumin Platelet-Rich Fibrin

Diabetes mellitus is a metabolic disease that can negatively affect wound healing and tissue repair. Albumin platelet-rich fibrin (Alb-PRF) is a blood-derived biomaterial used in periodontal and regenerative treatments. It contains growth factors and cytokines that may support tissue healing. The purpose of this study is to evaluate whether type 2 diabetes affects the biological composition of Alb-PRF. For this purpose, Alb-PRF samples obtained from individuals with type 2 diabetes will be compared with samples obtained from systemically healthy individuals. A total of 20 participants will be included in the study: 10 individuals with type 2 diabetes and 10 systemically healthy individuals. Venous blood samples will be collected from each participant, and Alb-PRF will be prepared using a standardized protocol. The prepared samples will be stored at -80°C until laboratory analysis. The levels of interleukin-6 (IL-6), epidermal growth factor (EGF), and insulin-like growth factor-1 (IGF-1) in Alb-PRF samples will be measured using an enzyme-linked immunosorbent assay (ELISA). These markers are related to inflammation, tissue repair, and wound healing. The results will help determine whether type 2 diabetes changes the cytokine and growth factor profile of Alb-PRF.

Specificities of Atypical Non AutoImmune Diabetes (ANAID) in the French West Indies

Genetics variants could be involved in atypical non-autoimmune diabetes revealed by ketoacidosis. The objective of this research will be to determine the relationships between the genetic variants already described in known monogenic diabetes or identified as involved in glucose metabolism and its regulation, in insulin signaling pathways or in insulin secretion itself in subjects of African and Indian ancestry with atypical forms of non autoimmune diabetes.

Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.

This study evaluates the effectiveness of a 3-month video-based lifestyle intervention, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with type 2 diabetes mellitus (DM2). Participants will be randomly allocated to receive the intervention either delivered by their own physician (experimental group) or by a physician unknown to them (control group). Assessment will include sociodemographic variables, glycated hemoglobin / HbA1c (primary outcome), body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to HbA1c, therapeutic alliance, age, and sex.

A Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions

This study was an open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the safety and pharmacokinetics of UI087 compared to coadministration of UIC202506, UIC202507 and UIC202508 in healthy adult volunteers under fasting conditions

Effect of the Digital Livsstilsverktyget in Conjunction With a Large Language Model on Glycemic Control in Patients With Type 2 Diabetes.

The overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. Users get access to expert-written information about relevant health topics and interact with an LLM to promote reflection on the information.

Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial

Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators have shown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a Hybrid Type 2 effectiveness-implementation trial using a cluster randomized stepped wedge design at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.