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Prediabetic State clinical trials

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NCT ID: NCT06137963 Withdrawn - PreDiabetes Clinical Trials

Digital Diabetes Prevention Program Study

Start date: January 24, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to determine if completion of the Diabetes Prevention Program (DPP) via the Transform 10 website can significantly decrease hemoglobin A1c (HbA1c) levels and Body Mass Index (BMI) in prediabetic individuals undergoing total hip arthroplasty (THA) procedure. As part of the standard procedure of the Centers for Disease Control (CDC)-approved DPP program, all study participants will report their active minutes and weight via the Transform10 website throughout the 6 month-long program. In addition, participants will have a repeat Hba1c test ordered at the end of the program by the medical director as part of routine procedures. The main questions it aims to answer are: 1. Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty? 2. Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty? 3. Is an augmented digital diabetes prevention program an effective strategy to improve postoperative outcomes and patient satisfaction in adults with prediabetes undergoing elective total hip arthroplasty? Participants will be randomized to get the DPP on their day of surgery (intervention group) or get their DPP 6 months after their day of surgery (control group). Comparing the intervention group to the control group, the researcher's primary outcome is change in percent of body weight before and after a 6-month intervention period.

NCT ID: NCT05726409 Withdrawn - Clinical trials for Diabetes Mellitus, Type 2

Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes

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

Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity including a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established, three-pronged approach places BMC in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population. For this first exploratory study, 75 enrolled participants will be given a free mobile application with recipes designed to build habits. Participants will cook at least three meals weekly for two months using the app. Self-reported survey data and activity on the app will be collected and used to assess the feasibility of teaching cooking skills through a mobile application.

NCT ID: NCT05720377 Withdrawn - Obesity Clinical Trials

Evaluation of Exercise Application Technology in Adolescents

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the use of an exercise phone application and a continuous glucose monitor and their impact on metabolic disease in adolescents with obesity, prediabetes and Type 2 diabetes. Participants will be asked to wear a continuous glucose monitor (Freestyle Libre) and if they are in the intervention group also participate in using an exercise phone application as well as have scheduled interval contact with a health professional in between scheduled clinic visits to assess how they are reaching their goals.

NCT ID: NCT05379296 Withdrawn - Hypertension Clinical Trials

Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age

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

Nearly half of women have obesity and/or hypertension (HTN). Specific to women, pregnancy creates a vulnerable window for excess gestational weight gain (GWG), exacerbating intergenerational risks for obesity, HTN, type 2 diabetes (T2D), and cardiovascular disease (CVD) across the lifespan. Healthy lifestyles are the first-line recommendations for prevention and treatment of overweight/obesity, HTN, T2D, and CVD. The Diabetes Prevention Program (DPP) is a well-established, Centers for Disease Control and Prevention (CDC)-led public health program focusing on healthy lifestyle changes and is effective at reducing 5-7% of body weight, lowering risks for T2D. Interestingly, research investigating the DPP as a lifestyle intervention for other chronic conditions (i.e., overweight/obesity and HTN) is lacking, demonstrating a missed opportunity. The aim of this study is to determine the initial effects of the first 6-months and after receiving the full 12-months of the virtual DPP compared to the DPP expanded with a CDC-approved HTN prevention component (DPP+) on physical activity, diet, weight, and CVD risk factors in 30 prediabetic women (18-45 years old) with a history of excess GWG, overweight/obesity, and HTN. Participants will be recruited through University of Texas Medical Branch (UTMB) community-based clinics using Epic. The Participants will be randomized into 2 groups (DPP and DPP+) and guided through the 12-month virtual DPP or DPP+ program using UTMB DPP personnel.

NCT ID: NCT05073237 Withdrawn - Obesity Clinical Trials

Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans

CE/BZA
Start date: April 8, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of a novel menopause hormone therapy on blood sugar (glucose) and blood and liver fats (lipids) in obese menopausal women Veterans.

NCT ID: NCT04029298 Withdrawn - PreDiabetes Clinical Trials

Home-based Prediabetes Care in Acoma Pueblo - Study 1

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

The prevalence of overweight, obesity and T2D among American Indians (AIs) in the Albuquerque service area of Indian Health Services (IHS) serving all pueblos in New Mexico including Pueblo of Acoma is disproportionately elevated. Specifically, among AI, adults age 18 and over in the IHS Albuquerque Service Area, 51% have a BMI > 30, which significantly exceeds the rate of obesity observed nationally (35.3%) and the Healthy People 2020 target of 30.5%. Likewise, the rate of T2D (22.8%) among the adult AI population in our Albuquerque service area is almost double the rate of the U.S. adult population (12.2%), and the age-adjusted diabetes mortality rate for AIs was 104.7 per 100,000 compared to 23.1 per 100,000 among non-Hispanic Whites in the region. At the same time, the median age of diagnosis of T2D among AI adults was much younger (42.2 years) than the national average (53.8 years). Our major goal of implementing educational interventions to slow the current rate of increase in diabetes in Native communities is aligned with NIH's (NIGMS) and NM INBRE's vision in reducing health disparity using innovative interventions. The investigators propose following aims: Aim 1: Recruit and Screen 300 community members in Acoma Pueblo, NM to identify incident cases of pre-diabetes for the proposed study of Home Based Diabetes Care (HBDC); Aim 2: Enroll 150 Acoma Natives aged 21-70 years, at risk for T2D (i.e., overweight, obese, and/or with at least one affected first degree relative or a history of gestational DM) and conduct HBDC for a 16-week lifestyle intervention in a longitudinal cohort study. Randomize household in a 1:1 allocation to enter either the intervention arm immediately or after a 12-month waiting list in control arm. Control participants will be treated with usual care. Participants randomized to the waiting list will enter the intervention group 12 months after entering the study. Both intervention groups will be followed longitudinally for total of 12 months. Compared with people who will receive "usual care (control group)", prediabetic participants receiving 4 months of the HBDC will exhibit improved risk factor profiles for diabetes, obesity and heart disease, improved Patient Activation Measures, improved adherence with medical treatment, and improved Quality of Life scores.

NCT ID: NCT03491930 Withdrawn - Obesity Clinical Trials

Weight Loss Using a Feedback Device in Obese People With the Metabolic Syndrome

Start date: June 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a weight loss app (VA MOVE!® Coach App) along with regularly scheduled telephone counseling, will motivate obese people with metabolic syndrome to lose weight and improve the symptoms of the metabolic syndrome, compared to usual weight loss approaches. This study will randomly assign participants to one of two groups, interventional or control. The interventional group will use the app with phone coaching and standard of care for weight loss. The control group will receive standard weight loss care without the app and phone coaching. Weight loss motivation to adopt life-style changes to maintain weight loss and quality of life between the two groups will be compared. The metabolic syndrome (MetS) is a cluster of disorders including high blood pressure, pre-diabetes, the tendency to carry body weight around the waist, and increased fat in the blood. When these problems happen together, there is an increased risk for heart attack, stroke, diabetes and certain cancers. Although the metabolic syndrome is a serious condition, it can be treated with diet, weight loss and increased activity. It can even be reversed using these lifestyle changes. Due to poor success with routine short-term weight loss treatment (group and one-on-one counseling), it is time to address the problem by a different method. Studies have shown feedback devices and weight loss apps have been successful in weight loss and weight maintenance. They are economical (many apps are free), and convenient to use, without attendance at group sessions. Since weight loss is the corner stone for improvement in the symptoms of the MetS, this study will offer a unique approach to support individuals who are committed to losing weight and adopting a healthier lifestyle. Numerous studies demonstrated that feedback via text messaging, and interaction through social networking support groups, in addition to iPhone apps, are all more effective in weight loss measures than group sessions at a hospital site. (Duncan et al., 2011; Greene, Sacks, Piniewski, Kil, & Hahn, 2012; Shaw et al., 2013; Spring et al., 2013). The benefit of these various methods is that they appear to accelerate weight loss and prevent weight re-gain if employed long-term. With technology changing daily, these approaches must be considered an essential adjunct to, or replacement for, traditional group counselling sessions.

NCT ID: NCT03315663 Withdrawn - Prediabetes Clinical Trials

Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes - Main Study

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.

NCT ID: NCT02881528 Withdrawn - Prediabetic State Clinical Trials

Autoimmune Diabetes Accelerator Prevention Trial

adAPT
Start date: March 30, 2016
Phase: Phase 4
Study type: Interventional

The autoimmune diabetes ACCELERATOR PREVENTION TRIAL (adAPT) is based on the accelerator hypothesis. The trial is designed to establish whether metformin, an oral hypoglycaemic agent that is known to reduce insulin demand in type 2 diabetes (T2D), can do the same in children at risk of type 1 diabetes (T1D) and thereby prevent disease. The first phase of adAPT will screen participants aged 5-16 years (inclusive) for islet-related autoantibodies who are the siblings or offspring of individuals diagnosed with T1D before the age of 25years in Scotland and England. There are four principle islet-related antibodies associated with T1D. The presence of two or more confers a 40% risk of developing T1D in five years. While the presence of none or one antibody carries a similar risk for developing T1D to the general population (1 in 500 in 5years). It is anticipated that 5% of those screened will be identified as double-antibody positive, these participants will be invited to join the intervention phase of the study - randomised controlled trial (RCT). Up to 200 eligible subjects could be identified by screening with a minimum of 90 being enrolled into the RCT phase. adAPT is a proposed three stage project. The current protocol defines the screening phase, Stage 1 and seamless entry into Stage 2. Screening will identify children and young people at high risk of developing T1D and invite them to participate in Stage 1 which will involve a minimum of 4 months treatment with either metformin/placebo, however Stage1 treatment will run seamlessly into Stage 2. Stage 1/2 treatment will last up to 21 months (to accommodate 15months screening, 4 months treatment and 2 months analysis). Post Stage1 analysis/ late Stage 2 participation will last up to 36 months (participants enrolled early into Stage 1 will have the longest intervention). During the Stage1 participants will be tested on three occasions (baseline, month 1 and month 4) for metabolic response using a 5-point mixed meal tolerance test (MMTT). Testing will continue in Stage 1/2 with 3 visits further visits at months 8, 12, 18. Late Stage 2 visits will occur on months 24, 30 & 36. Participants will be invited to continue into Stage 3, taking treatment up to 60 months post analysis of Stage 1 and associated protocol amendment and additional consent.

NCT ID: NCT02532088 Withdrawn - Prediabetes Clinical Trials

Modulating Effects of Oil Palm Phenolics in Subjects With Pre-diabetes

PREDOPP
Start date: May 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in this spontaneous diabetes model. The present study aims to determine the beneficial effects of Oil Palm Phenolics in subjects with pre-diabetes.