Clinical Research Directory

OBEDIAM: Therapeutic Patient Education in Adults Living With Obesity, Diabetes, and Metabolic Disorders

The goal of this observational study is to learn about the acceptability and feasibility of a therapeutic patient education program in adults living with an obesity. The main question it aims to answer is: Is the intervention of therapeutic patient education acceptable for patients living with an obesity? Participants will answer questionnaires and participate to focus groups before and up to nine months after the intervention.

Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)

The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and inadequately controlled Type 2 Diabetes (T2D) despite guideline-directed therapy, including Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)-based agents.

Frontal EEG Dynamics During Anesthesia in Patients With Obesity and Normal Weight

This prospective observational study aims to compare frontal electroencephalographic (EEG) spectral dynamics between patients with obesity and normal weight undergoing general anesthesia. The primary objective is to evaluate whether changes in frontal alpha power around propofol-induced loss of consciousness differ between the two BMI groups. Secondary objectives include comparing changes in delta power, the alpha/delta power ratio, and frontal alpha asymmetry around loss of consciousness, as well as evaluating EEG spectral dynamics throughout the intraoperative period. Anesthetic management will be determined by the attending anesthesiologist according to routine clinical practice, without intervention by the study investigators.

Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide

Incretin-based pharmacotherapies induce significant weight loss and represent a paradigm shift in obesity treatment. However, particularly fast weight loss may be accompanied by a significant loss of muscle mass, which is associated with a reduced metabolic rate at rest and during physical activity, increased insulin resistance, limited mobility, and potential long-term adverse effects. The aim of this clinical trial is to examine the effects of resistance training versus standard of care on contractile thigh muscle volume in patients receiving the dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists 'tirzepatide'.

Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders

This is a multicentric, prospective, intervention study on circadian genes expression in peripheral blood mononuclear cells as biomarkers of circadian rhythm derangement in patients affected by alterations of endogenous glucocorticoids secretion (Cushing's Syndrome during active phase, treatment and under remission and newly or on established glucocorticoid replacement therapy adrenal insufficiency)

Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS

Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. This randomized, controlled, open-label, parallel-group trial aims to compare the effects of a Mediterranean diet (MD) and a low-carbohydrate diet (LCD), each combined with metformin, inositol, or folic acid (active control), in obese women with PCOS and IR. A total of 102 participants will be randomly assigned to one of six intervention groups and followed for two months. Anthropometric measurements, body composition, biochemical parameters, and hedonic hunger will be assessed at baseline and after the intervention. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to 2 months. Secondary outcomes include changes in body composition, metabolic and biochemical parameters, and hedonic hunger.

Peripheral Vascular Effects of Insulin in Obesity

Successful completion of this project will advance our understanding of the role sympathetic nervous system overactivity plays in driving skeletal muscle malperfusion during hyperinsulinemia and consequently impaired glucose uptake in obesity.

Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity

Determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation.

Body Mass Index and Outcomes of Ultrasound-Guided Infraclavicular Brachial Plexus Block

This study aims to investigate whether body mass index (BMI) is associated with differences in the time needed to perform an ultrasound-guided infraclavicular nerve block and how well the block works. This type of regional anesthesia involves injecting a local anesthetic near the nerves below the collarbone to numb the arm for surgery. The study will include 100 adults undergoing planned hand, wrist, or forearm surgery at Ankara Bilkent City Hospital. Researchers will compare 50 participants with a BMI below 30 kg/m² and 50 participants with a BMI of 30 kg/m² or higher. The study will assess the time needed to perform the block, block success, the time until sensation and movement are blocked, and patient satisfaction. Researchers will also examine whether arm circumference and muscle measurements are associated with block outcomes. This is an observational study. Participants will receive routine anesthesia and surgical care, and their treatment will not be assigned or changed for research purposes.

NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity

Obesity is a complex health condition defined by the World Health Organization (WHO) as an excess of body weight that may be harmful to health. It leads to other diseases such as type 2 diabetes or cardiovascular diseases, commonly referred to as "co-morbidities." Among these, it is known that obesity increases the risk of developing infectious diseases and of these diseases progressing to severe stages. During the COVID-19 pandemic and the 2009 H1N1 influenza epidemic, a rise in severe infection cases was observed in people with obesity. A part of people with obesity exhibits certain markers on the surface of their immune cells, which are known to cause immunosuppression when present in high numbers, thus increasing the risk of developing infectious diseases. Investigator teams found that after bariatric surgery and a calorie-restricted diet for weight loss, patients with obesity can improve the levels of these immunity-related markers. Moreover, the choice of foods consumed contributes to strengthening the immune system and immune functions of individuals, both directly by influencing inflammation and indirectly through the microbiota. However, to date, there are no dietary recommendations specifically designed to help people with obesity improve their immune response. Therefore, this study aims to compare different dietary recommendations intended to improve immune status, with or without calorie restriction, during 3 months, in individuals with obesity (BMI ≥ 30 kg/m²) and impaired immunity. Over 6 months (3 months of nutritional intervention and 3 months of follow-up), investigators will collect extensive information through biological samples, measurements and questionnaires to compare the different dietary interventions studied and to understand the mechanisms behind the results obtained.

Comparison Between the Health Effects of an AI-driven Model With Those of Human Professional Guidelines for the Treatment of Obesity

Many non-communicable diseases are diet-related and have a significant impact on public health. It is stated that global dietary shifts are needed to change disease patterns, highlighting the importance of nutrition in addressing public health issues, such as obesity. The field of nutrition has been dependent on clinical and observational studies; however, the emergence of Artificial Intelligence (AI) is transforming these approaches. ChatGPT may be used to provide dietary recommendations due to its high speed, extensive access to a variety of meal data, and low complexity. However, initial evaluations have shown that ChatGPT may be inaccurate in terms of safety and reliability, and traditional nutrition approaches are highly reliant on experts' knowledge and the validity of nutritional guidelines. It has been suggested that AI in nutrition may be beneficial; however, further investigations are needed. Our proposal aims to fill the represented critical evidence gaps. The study aims to compare the health effects of an AI-driven model with those of human professional guidelines for the treatment of obesity. Furthermore, investigators seek better strategies to utilize AI, if appropriate, for weight loss and other health benefits.

Mazdutide for Weight Management and Gout in Adults With Obesity

This is a single-arm, open-label, pre-post controlled study to evaluate the effect of Mazdutide on the annualized flare rate (AFR) in adults with obesity and gout. The study will enroll 30 subjects aged 18 to 65 years with a Body Mass Index (BMI) ≥ 30.0 kg/m². Eligible participants must have a confirmed diagnosis of gout and a history of at least 2 gout flares in the past 6 months. The primary objective is to compare the AFR during the 52-week treatment period with the 12 months prior to treatment. All subjects will receive Mazdutide with a dose-escalation regimen, and their outcomes will be compared to their own baseline data.

Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea

Obesity-related sleep hypoventilation represents a continuum ranging from isolated nocturnal hypoventilation to obesity hypoventilation syndrome. Current diagnostic criteria rely mainly on dichotomous thresholds and may not adequately reflect cumulative nocturnal carbon dioxide exposure. Hypercapnic burden, defined as the cumulative area under the transcutaneous carbon dioxide (PtcCO₂) curve above a predefined threshold, has recently emerged as a novel physiological marker integrating both the intensity and duration of nocturnal hypercapnia. This prospective observational cohort study aims to evaluate the association between nocturnal hypercapnic burden and obstructive sleep apnea severity, assessed by the apnea-hypopnea index (AHI), in adults with obesity referred for diagnostic polysomnography. Secondary objectives include evaluating associations between hypercapnic burden and sleep architecture, respiratory events, oxygenation parameters, daytime symptoms, and patient-reported outcomes. In addition, the study will investigate the relationship between nocturnal hypercapnic burden and sleep inertia, assessed using the Sleep Inertia Questionnaire (SIQ), based on the hypothesis that greater nocturnal carbon dioxide exposure immediately before awakening may contribute to impaired alertness upon awakening. Hypothesis: Increased nocturnal hypercapnic burden is associated with greater obstructive sleep apnea severity and reflects an additional physiological dimension of obesity-related sleep hypoventilation beyond conventional polysomnographic indices. Furthermore, higher nocturnal hypercapnic burden is hypothesized to be associated with greater sleep inertia.

Pilot Study of Endoscopic Sleeve Gastroplasty for Obese Patients With Heart Failure and Preserved Ejection Fraction

This is a small research study to see whether losing weight with a minimally invasive weight-loss procedure called endoscopic sleeve gastroplasty (ESG) can help improve symptoms of a type of heart failure called HFpEF in adults with obesity.

Assess the Effects of Replacing Foods High in Refined Carbohydrates With Avocado on Biomarkers of Inflammation.

The objective of this trial is to assess the effects of replacing foods high in refined carbohydrates, particularly added sugars, with avocado (isocaloric substitution) on biomarkers of inflammation and insulin sensitivity in adults with elevated hs-CRP and central adiposity. Eligible participants will complete two 4-week interventions (1 avocado/d and control) separated by a 2-week washout phase. Participants will complete a total of 7 clinic visits including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 4-week diet condition (visit 3 \& 6 on day 21 and visits 4 \& 7 on day 28), and one visit at the conclusion of the washout phase/start of the second condition (visit 5, day 0).

Effect of Tocopherol and Ascorbic Acid on Neuroinflammation Markers Associated With Neuropeptide Expression in the AgRP/NPY and POMC Pathways in Mexican Population With Obesity

This clinical trial will determine whether taking ascorbic acid (vitamin C), α-tocopherol (vitamin E), or both together can lower markers of brain inflammation and change the expression of neuropeptides in Mexican adults with obesity. Main Questions The study aims to answer: 1. Does vitamin C, vitamin E, or both reduce neuroinflammation? 2. Do these supplements change the expression of neuropeptides linked to obesity? Comparison Groups Researchers will compare the effects of vitamin C alone, vitamin E alone, and the combination of both to see if they improve brain health in people with obesity. What Participants Will Do Participants will: 1. Take vitamin C, vitamin E, or both daily, depending on their assigned group 2. Attend clinic visits once every 2 weeks for and tests for checkups and tests for record and report supplement intake so that researchers can monitor and evaluate treatment adherence 3. Provide samples and health information to measure inflammation and neuropeptides , at the beginning of the intervention and at 12 weeks, when the intervention ends.

FABP4 Response After Roux-en-Y Gastric Bypass

This retrospective observational cohort study examined serum fatty acid-binding protein 4 (FABP4) dynamics in 28 adults who underwent Roux-en-Y gastric bypass (RYGB), followed at baseline, 3 months, and 6 months. Anthropometric, metabolic, and inflammatory parameters were assessed alongside FABP4, fasting GLP-1, and PYY. Patients were classified as FABP4 responders (decrease from baseline to 6 months) or rebound/non-responders. The study investigated whether FABP4 trajectory after RYGB is associated with the magnitude of weight loss, systemic inflammation, and fasting incretin change.

Exercise and Taurine Supplementation on Intramuscular Fat in Older Women With Obesity

This randomized clinical trial aims to investigate the effects of multicomponent concurrent exercise training associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, transcriptomic profile, and metabolomic profile in older women with obesity. Forty women aged 60 to 75 years with obesity will be randomized into four groups: control, exercise, taurine, and exercise plus taurine. The intervention will last 16 weeks. Outcomes include magnetic resonance imaging, body composition, muscle biopsy, blood biomarkers, functional capacity tests, transcriptomic analysis, and metabolomic analysis.

Semaglutide for Low Back Pain

Low back pain is the leading cause of disability in the United States, and obesity is a major risk factor for its development. GLP-1 receptor agonists such as Semaglutide have emerged as effective weight loss agents that may also reduce chronic pain through weight reduction and other mechanisms. This randomized, double-blind, placebo-controlled trial will enroll 250 adults with chronic low back pain and obesity, randomized 1:1 to weekly Semaglutide 2.4 mg or placebo for 52 weeks. The primary outcome is change in low back pain severity, with secondary outcomes including pain-related disability and quality of life.

Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise

Population aging has been accompanied by a rise in obesity and other chronic diseases, increasing cardiovascular risk particularly among women, who exhibit a higher prevalence in older age groups compared to men. Aging and obesity share pathophysiological mechanisms, such as chronic inflammation and oxidative stress. However, distinct obesity phenotypes exist, such as metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO). Consequently, therapeutic interventions involving nutritional strategies and physical training are highly relevant, especially for older women. Taurine, a sulfur-containing amino acid, plays a role in modulating oxidative stress, inflammation, osmoregulation, and mitochondrial function. Rationale: Plasma taurine concentrations are lower in women with obesity compared to healthy individuals. However, studies investigating these concentrations across different phenotypes-particularly in older women, a group susceptible to functional and metabolic changes-remain limited. Understanding these variations could clarify taurine's role in the pathophysiology of obesity and aging and inform personalized therapeutic strategies. Combined physical training stands out as an effective strategy for modulating inflammatory, oxidative, and metabolic pathways, in addition to improving psychosocial aspects. Given that taurine levels can be influenced by these pathways, investigating the taurine response to physical training across different metabolic phenotypes may contribute to developing low-cost interventions aimed at improving the quality of life for older women with obesity.

MRI Assessment of Body Composition in Bariatric Surgery

The goal of this observational study is to evaluate changes in adipose tissue and skeletal muscle distribution using magnetic resonance imaging (MRI) in adults with obesity undergoing bariatric surgery. The study also aims to investigate the relationship between MRI-derived body composition parameters and metabolic outcomes following surgical treatment of obesity. The main questions it aims to answer are: How does bariatric surgery affect the distribution of visceral, subcutaneous, hepatic, perirenal adipose tissue and skeletal muscle over 12 months? Are changes in MRI-derived body composition associated with improvements in metabolic parameters after bariatric surgery? Participants will: undergo MRI examinations before bariatric surgery and at 1, 6, and 12 months after surgery; undergo routine clinical and metabolic assessments during standard postoperative follow-up; have MRI-derived body composition measurements correlated with metabolic outcomes over the 12-month follow-up period.

The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix

The interventional study will recruit four groups (n=10 per group): Young men and women with normal weight (BMI 18-25), and young men and women with obesity (BMI \>30). The study will investigate the effect of 84 hours of fasting on peak fat oxidation, mitochondrial coupling and the extracellular matrix.

Allurion Gastric Balloon PAS

The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).

Impact of Exercise Prescription on Obstetric and Neonatal Outcomes

The aim of this study is to assess the impact of structured physical activity with smartwatch remote monitoring on glycemic control, blood pressure control, obstetric complications and neonatal outcomes in women with GDM, chronic hypertension and obesity. A prospective, longitudinal, single-arm intervention study with 310 pregnant women was conducted over a period of 18 months. Participants received individualized exercise prescriptions based on international guidelines, complemented by smartwatch monitoring and regular telephonic feedback. Outcomes were compared between subgroups of women who adhere to the recommended exercise guidelines and those who did not, across three high-risk populations (GDM, chronic hypertension and obesity).