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Prediabetic State clinical trials

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NCT ID: NCT05563090 Recruiting - Healthy Clinical Trials

Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools

Start date: September 17, 2022
Phase:
Study type: Observational

The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment. This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic. A total of 250 subjects with 50 allocated in each group will be recruited to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-65 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included. Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis.

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: NCT05560412 Completed - Clinical trials for Overweight and Obesity

Zein Nanoparticles for Glycemic Control

GLUCOCAPS
Start date: January 10, 2023
Phase: N/A
Study type: Interventional

The use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. The objective is to assess the efficacy of zein nanoparticles on the glycemic control. For this purpose, a randomized, double blind crossover study has been designed. Target sample size is 60.

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: NCT05544825 Completed - Clinical trials for Impaired Fasting Glucose

Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose

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

The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of ice plant (Mesembryanthemum crystallinum) extract in patients with impaired fasting glucose for 12 weeks.

NCT ID: NCT05540405 Completed - PreDiabetes Clinical Trials

Effects of Bitter Melon on Cardiometabolic Health

Start date: January 24, 2023
Phase: N/A
Study type: Interventional

The objectives of this study are to assess the effects of a bitter melon product at two doses, compared to control, on indicators of cardiometabolic health among men and women with prediabetes.

NCT ID: NCT05531838 Not yet recruiting - PreDiabetes Clinical Trials

Prediabetes Management

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

Systematically screen the high-risk population of diabetes in Xinqiao district to understand the characteristics of early glucose metabolism changes and pancreatic islet function changes in patients with pre diabetes. Relying on MMC platform and combined with CGM therapeutic monitoring technology to standardize the management of patients with prediabetes, it is expected that the annual conversion rate of diabetes in patients with prediabetes will be 8% (according to the literature, if the pre diabetes population is not intervened, the annual conversion rate of diabetes will be about 14%), which will move forward the management of diabetes and create a new mode of pre diabetes management.

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: NCT05497960 Completed - PreDiabetes Clinical Trials

Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes

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

This research trial studies the effect of an online, live and interactive strength training program on physical function and strength in older adults with prediabetes.

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.