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NCT ID: NCT05280925 Recruiting - Type 2 Diabetes Clinical Trials

Episodic Future Thinking to Improve Management of Type 2 Diabetes: Remote Delivery and Outcomes Assessment

Start date: July 20, 2022
Phase: N/A
Study type: Interventional

Successful management of type 2 diabetes (T2D) requires adherence to a dietary, physical activity, and medication plan agreed upon between a patient and their healthcare providers. The lifestyle changes involved in these collaborative care plans (CCPs) often provide little to no short-term benefit and may instead be aversive (e.g., caloric restriction and physical activity). However, these changes provide critical health benefits in the future, allowing patients with T2D to halt or reverse disease progression and avoid T2D-related complications (e.g., renal disease or diabetic retinopathy). Thus, successful management of T2D requires one's present behavior to be guided by future outcomes. Unfortunately, accumulating evidence indicates that individuals with T2D and prediabetes show elevated rates of delay discounting (i.e., devaluation of delayed consequences). Moreover, high rates of delay discounting are cross-sectionally and longitudinally associated with poor treatment adherence and clinical outcomes in T2D and prediabetes. These data suggest that high rates of delay discounting prevent successful management of T2D through a mechanism in which the health benefits of lifestyle changes are too delayed to motivate behavioral change. Thus, we believe delay discounting serves as a therapeutic target in T2D, where improving participants' valuation of the future will facilitate healthy lifestyle changes and, in turn, improve T2D management. This study will conduct a randomized 24-week remote clinical trial comparing repeated measures ANOVA, with group (episodic future thinking [EFT]/control) and area (urban vs. rural) as between-subjects factors, and time (baseline, week 8, and week 24 assessments) as within-subjects factors in adults with type 2 diabetes.

NCT ID: NCT05277558 Recruiting - Inflammation Clinical Trials

Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)

Metabrain
Start date: May 24, 2022
Phase:
Study type: Observational

Investigators propose to study youth across the spectrum of body mass index (BMI) and dysglycemia. This approach will allow investigators to disentangle the relationship of key features of type 2 diabetes (T2D) risk (e.g. obesity) with intermediary physiologic changes (e.g. insulin resistance, inflammation, β-cell dysfunction and dysglycemia) that pose a risk for the brain. Investigators will determine which of these factors are most associated with differences in brain structure and function among groups, over time, and how these effects differ from normal neurodevelopment.

NCT ID: NCT05277532 Recruiting - Overweight Clinical Trials

Effect of Circadian Rhythm and Physical Exercise in Overweight Type 1 Diabetes Patients

Start date: May 18, 2022
Phase: N/A
Study type: Interventional

Cardiometabolic risk in patients with abdominal obesity and type 1 diabetes can be moderated by life style modifications. There is an intimate link between gene regulation and circadian rhythm in mediating response to exercise in a variety of insulin sensitive organs. The aim of this project is to evaluate, by intervention, the interplay of circadian rhythm and high intensity interval training (HIIT) on glucose control and skeletal muscle metabolism in patients with overweight with or without type 1 diabetes (T1D).

NCT ID: NCT05273892 Completed - Clinical trials for Overweight or Obesity

The KING'S WHOLE Feasibility Study

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

Office working life has changed dramatically over the last 50 years with digitalization; this is estimated to have decreased the amount of energy (calories) used during work. Employees who work long or irregular working hours or experience job strain are more likely to make less healthy food choices. The combination of these factors may contribute to increased body weight during a persons working life. The aim is to investigate the feasibility of an online lifestyle behaviour change intervention in office workers.

NCT ID: NCT05260762 Completed - Clinical trials for Overweight and Obesity

Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype

POMFAME
Start date: April 13, 2022
Phase: N/A
Study type: Interventional

The overall aim of this 12-week randomized controlled trial is to investigate if a dietary fiber supplement rich in arabinoxylans (AX) affects weight loss success differently according to baseline gut microbiota composition in subjects who have overweight or obesity. 105 participants will be randomized in a 2:1 ratio to receive 15 g/day of AX or placebo.

NCT ID: NCT05255367 Completed - Clinical trials for Overweight and Obesity

Effect of (Poly)Phenolic on Cardiometabolic Risk of Postmenopausal Women

CARDIOGENE
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this investigation is to test the hypothesis that in post-menopausal women with cardiometabolic risk, eating a relatively high daily amount of (poly)phenol-containing products (green tea, dark chocolate and berries) could reduce the risk of metabolic syndrome and cardiovascular disease. Changes in different biomarkers of lipid metabolism, glucose metabolism, inflammation and oxidative stress will be evaluated. Other related factors may be also affected, such as body mass index (BMI) and the percentage of body fat, dietary habits (total energy intake and macronutrient distribution) and microbiota composition.

NCT ID: NCT05254158 Completed - Clinical trials for Overweight and Obesity

A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity

Start date: March 3, 2022
Phase: Phase 1
Study type: Interventional

The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body. The study compares three different doses of the study medicine in Chinese healthy men. Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance. NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation. We are testing the study medicine to make a medicine that can help people lose weight. Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 5 months. But participants participation will last about 2 months. Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay. At all visits, except the information visit, participant will have blood drawn along with other clinical examinations. Participants will be asked about their health, medical history and habits including mental health.

NCT ID: NCT05253768 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus

SETOM
Start date: March 2024
Phase: Phase 2
Study type: Interventional

The main purpose is to evaluate whether the percentage of body weight change from baseline to week 12 is higher than that in the placebo group. In this randomized, double-blind, placebo-controlled study, 39 patients fulfilling the study criteria will be enrolled in the study. Patients will be randomized(2:1) to either FMT or placebo.

NCT ID: NCT05252013 Completed - Healthy Clinical Trials

The Impact of Broad Bean Hull on Blood Glucose Control and Gut Health

Start date: January 31, 2019
Phase: N/A
Study type: Interventional

This study aims to assess the effects of broad bean hull (BBH) consumption on blood glucose and gut health. Broad bean (Vicia faba) is widely cultivated in Scotland, with the UK being the most significant European producer. The seed coat (hull or testa) is removed during broad bean processing. This is a significant secondary product that is largely discarded. Preliminary work showed that this material is comparable to wheat bran and is rich in fibre (49%) and protein (18%). Additionally, it showed a rich phytochemical profile and lower fat and carbohydrate content than wheat bran. Experiments also showed that BBH inhibited the activity of alpha-amylase and alpha-glucosidase enzymes, suggesting anti-diabetic properties. Overall, these results showed that BBH is a secondary crop product having potential as a functional food for humans. Therefore, the objective of this study is to assess in vivo in humans the physiological and functional effects of BBH. Using an acute phase randomised controlled crossover design, the study will assess how consuming BBH fortified breads affects plasma glucose and gut health. The study will recruit 18 volunteers, normal-overweight, aged 18-75 years, who habitually consume low amounts of fruits and vegetables (≤3 portions/day). The volunteers will attend two identical stand-alone intervention sessions lasting three days each following the screening. The order of the intervention sessions will be randomised. On the day before each intervention session, the participants will provide a baseline faecal sample and have a continuous glucose monitoring sensor (CGMS) attached. They will be also be given a standardised dinner. On the next morning, following a 10-12 hr fast, an indwelling antecubital cannula will be inserted, and a blood sample will be taken for measuring baseline levels of metabolites. The volunteers will be given a standardised portion of the BBH or control bread to consume, and further blood samples taken for the subsequent four hours. Breath samples will also be taken at the same time points for measuring gastric emptying. The volunteers will be provided with all the meals for the rest of the day and the subsequent two days. These will include two portions per day of either the BBH or control bread. The meals will be standardised for energy and macronutrients. The volunteers will be instructed to return to the Human Nutrition Unit on the fourth morning and provide a second faecal sample and remove the CGMS. Blood samples will be analysed for systemic bioavailability and metabolism of test meal components, glucose regulatory hormones and breath samples for quantifying gastric emptying. The faecal samples will be analysed for gut bioavailability and metabolism of test meal components, microbial counts, composition, and water content.

NCT ID: NCT05249465 Recruiting - Obesity Clinical Trials

Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention

Start date: September 22, 2023
Phase: N/A
Study type: Interventional

This optimization trial will examine three tracking (or "self-monitoring") strategies for weight loss -- tracking dietary intake, steps, and/or body weight -- all delivered through digital health tools. The purpose of the study is to evaluate the combination of these strategies that maximizes 6-month weight loss in the context of a standalone digital health intervention for adults with overweight or obesity. The investigators will recruit 176 total participants to the trial. Recruitment will occur through remote channels. Interested individuals will be directed to an online screening questionnaire; those who are eligible will then be invited to attend an initial remote session with study personnel to ensure interest and eligibility in the study. The weight loss intervention will last 6 months, and all participants will receive a "core" treatment consisting of goal setting, behavioral lessons, action plans, and tailored feedback - all of which will be delivered remotely. Depending on which group participants are assigned to in the study, some individuals will be asked to track their dietary intake, their steps, and/or their body weight via digital tools. All study tasks will occur remotely, thus, participants never need to come in-person for any intervention or assessment tasks. The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify the most effective combination of self-monitoring strategies. The factorial design will allow the research team to determine the unique and combined impact of each self-monitoring component on weight change. The primary outcome is weight change from baseline to 6 months. The research team will also assess self-monitoring engagement over 6 months and its association with weight change. To complement the main trial, the research team will also randomize half of participants to receive an interactive orientation video, in order to assess its impact on trial retention at 6 months. Overall, the information gathered from this trial will enable the construction of an optimized digital health intervention for weight loss that can be delivered remotely, which, if found to be effective, could have high potential for scalability.