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Prediabetic State clinical trials

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NCT ID: NCT05560971 Recruiting - Obesity Clinical Trials

Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes

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

The purpose of this study is to understand and determine whether Palmitoleic acid (POA), monounsaturated omega-7 fatty acid (exists in regular diet), improves insulin sensitivity and decreases liver fat accumulation in humans. Unlike others, the study will use POA as a dietary supplement, rather than complex oils, which contain a significant amount of saturated fat palmitic acid. Palmitic acid has known harmful effects on the body. Hence, eliminating palmitic acid from supplementation of POA might increase its benefits. This trial stems from the preclinical discoveries that POA acting as a fat hormone, has beneficial effects on the liver, muscle, vessels, and fat tissue. Supporting this, higher POA levels in humans have been shown to be correlated with a reduced risk of developing type-2 diabetes and cardiovascular diseases such as heart attacks. In animals, it has been observed that POA improves sugar metabolism in a number of mechanisms related to the liver and muscle. Based on these findings, the design of this study is a double-blind placebo-controlled trial that tests the effects of POA on insulin sensitivity of overweight and obese adult individuals with pre-diabetes.

NCT ID: NCT05559515 Recruiting - PreDiabetes Clinical Trials

Patient-centered Goal Setting in the National Diabetes Prevention Program

NDPP-Flex
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This is a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP to evaluate effects on glycemia, heterogeneity of treatment effects, and mechanisms of change. We will recruit 200 diverse adults with prediabetes (A1C 5.7-6.4%) and normal weight or overweight/obesity. Participants will enroll in classes (N=20) that are randomized to deliver NDPP-Flex or the standard NDPP. The trial is designed to have >95% power to detect anticipated treatment effects of ~0.2% A1C improvement and ~10% increase in participants who reach normoglycemia compared to the control arm. The study will be conducted in a health system with the 6th largest network of FQHCs in the US (Denver Health) and in partnership with a premier research institution (University of Colorado).

NCT ID: NCT05505565 Recruiting - Obesity Clinical Trials

Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes

Start date: June 5, 2023
Phase: N/A
Study type: Interventional

We are evaluating whether intermittent use of continuous glucose monitors (CGMs) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (PD).

NCT ID: NCT05492916 Recruiting - PreDiabetes Clinical Trials

Integrating Cultural Aspects Into Diabetes Education

INCLUDE
Start date: June 27, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to examine the efficacy of the video-based Diabetes Prevention Program (DPP) + Community-supported agriculture (CSA) (hereafter INCLUDE) intervention compared with a wait-list control group (hereafter CONTROL) on diabetes prevention among Chinese immigrants with T2D in NYC. Participants will be randomized with equal allocation to one of the two groups. The INCLUDE group will receive one culturally tailored DPP brief video/week for 24 weeks delivered via WeChat. They will also have access to the CSA program that Co-I Dr. Stella Yi has built in existing and ongoing community-partnered work in Brooklyn Chinatown. The CONTROL group will continue to receive their usual care and, at the end of the study, they will receive DPP videos. Measurements will occur at baseline, 3, and 6 months. This study will provide critical information on whether it is efficacious to use an existing social media platform plus CSA support to enhance access to DPP. If the intervention is proven efficacious, this project can provide important data for future scaling of this intervention. This study may serve as a transformative new model to enhance access to culturally tailored diabetes education and promote health equity for underserved limited English proficiency (LEP) immigrant and minority groups.

NCT ID: NCT05441982 Recruiting - Insulin Sensitivity Clinical Trials

Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes

Start date: September 21, 2023
Phase: N/A
Study type: Interventional

Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of saccharin, but not acesulfame potassium, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.

NCT ID: NCT05435196 Recruiting - Prediabetic State Clinical Trials

Efficacy of High-intensity Exercise in Women With Prediabetes

Prediabetes
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

About 382 million of adults in the world have Diabetes type 2 (DT2), and it is foreseen that this number will increase to 592 million in 2035. International Diabetes Federation (IDF) (2017) established that 352 million adults around 20 and 79 years old (which is 7,3% of that population), could be classified as prediabetes. This last is characterized by the resistance to insulin of skeletal muscle, of the liver and/ or adipose tissue, provoking the excessive e insulin secretion of β cells and pancreatic exhaustion which produce severe hyperglycemia. The High-intensity interval training (HIIT) can increase the oxidation ability, relating directly to insulin sensibility.

NCT ID: NCT05426525 Recruiting - Clinical trials for Overweight and Obesity

Use of Empagliflozin to Treat Prediabetes

Start date: October 13, 2022
Phase: Phase 4
Study type: Interventional

The overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Our aims are to: 1) Test the ability of empagliflozin to improve regulation of glucose metabolism (i.e., blood sugar) among overweight and obese individuals at risk for diabetes, and 2) Identify mechanisms to explain how empagliflozin may improve skeletal muscle glucose metabolism. We hypothesize empagliflozin will improve regulation of glucose metabolism due to changes in whole-body and skeletal muscle metabolism (e.g., increased rates of whole-body fat oxidation, evidence of impaired skeletal muscle mitochondrial respiratory function and increased energetic stress, lower accumulation of skeletal muscle lipids and improved skeletal muscle insulin signaling compared with placebo treatment).

NCT ID: NCT05421390 Recruiting - PreDiabetes Clinical Trials

Effect of Dairy Products on Insulin Resistance

Start date: June 10, 2022
Phase: N/A
Study type: Interventional

The objective of the study is to determine the effect of dairy consumption on insulin sensitivity in overweight and obese adults with prediabetes. Men and women (30-65 y) will be recruited from the greater Montreal area. Upon screening, those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 serving/d of reduced-fat dairy. Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d of reduced-fat or regular-fat dairy for 12 weeks. Participants will be instructed on how to incorporate foods into their diet in a manner that prevents changes in their body weight. The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome. In addition, glycemic variables, body composition, and cardiometabolic risk factors will be assessed as secondary outcomes. Serum lipidomic and global gene expression responses to the intervention in subcutaneous adipose tissue will be measured as exploratory variables. Adherence to intervention will be assessed at each visit by food diaries, a record of consumed dairy products, and serum proportion of 15:0, 17:0, and t16:1n7 fatty acids as objective biomarkers of dairy fat intake.

NCT ID: NCT05413928 Recruiting - Healthy Clinical Trials

Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to study the temperature/heart rate response to different meals in different people.

NCT ID: NCT05372445 Recruiting - Obesity Clinical Trials

Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention

MicrobiAr
Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The incidence of type 2 diabetes worldwide is growing rapidly, being one of the fastest growing global health emergencies of the 21st century according to the International Diabetes Federation. In MicrobiAr the investigators seek to achieve type 2 diabetes remission through a plant-based diet and lifestyle intervention identifying and characterizing key changes on the gut microbiome during clinical transitions. Specifically, the investigators aim to characterize and follow-up metabolic pathways from gut microbiome and how they evolve as long as health indicators do over the 2 years of this study.