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107 active trials for Prediabetes

Randomized Trial of Exercise Promotion in Primary Care

Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.

Start: July 2020

An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer

This is a first-in survivor, single-arm pilot study with the goal of establishing evidence of feasibility and safety of a combined pharmacologic (metformin) and lifestyle intervention (using an existing digital platform) to prevent diabetes in prediabetic adult survivors of childhood cancer. Primary Objective The primary aim of this proposal is to establish the feasibility and safety of a 24-week combined metformin + intensive lifestyle intervention among adult survivors with prediabetes. Primary endpoints of this trial will be adherence to 1) daily metformin administration and 2) completion of required core-curriculum of the lifestyle change intervention. Safety will be assessed using the Global Rating of Side Effects Burden Secondary Objectives The secondary aim is to assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on glycemic control and insulin resistance. Glycemic control will be measured by fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) and insulin resistance measured by the homeostatic model assessment (HOMA-IR) and IGF- binding protein 1 (IGF-BP1; a measure of insulin sensitivity strongly correlated with euglycemic insulin clamp testing). Exploratory Objectives To assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on weight, other anthropometric measures, blood pressure and lipid profile, physical activity (self-reported and as measured by accelerometer), frailty measures, and health-related quality of life (HRQOL). We will also assess diabetes development at future SJLIFE visits. To assess measures of participation in the lifestyle change program as well as barriers to participation and medication adherence.

Start: July 2021

Behavioral Economics for Activity Motivation in Adolescents (BEAM)

There is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (AYA) with type 2 diabetes (T2D), who often have very low levels of physical activity. The BEAM Trial is a proposed mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes.

Start: July 2021

WorkWell: Work-based Activity and Metabolic Health

This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments.

Start: March 2021

Home-based Prediabetes Care in Acoma Pueblo - Study 1

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.

Start: June 2021

Effect of a Probiotic on the Glycemic Profile and the Fecal Microbiota of Prediabetic Subjects (PREDIABETCARE)

According to the data from the Di@bet.es study, which is part of the National Diabetes Strategy, the prevalence of type 2 diabetes among Spanish population is 13.8%. Diabetic patients suffer from several short and long term complications, which are related to a significant worsen of quality of life and a substantial increase in death rate. In this sense, it is important to prevent the development of Type 2 diabetes. Therefore, it is of high relevance to identify and to treat prediabetic subjects prior to the development of the disease. Many strategies have been implemented to reverse this situation, such as changes in diet and lifestyle, among others. However, it is hard to achieve changes in lifestyle and despite the use of some drugs in this phase of the disease, the problem continues growing. For this reason, new strategies to combat the development of type 2 diabetes are been investigated, such as the use of probiotic formulations. However, at the moment, few studies evidence the effect of probiotics on glycemic regulation. Therefore, an interesting opportunity arises according to the potential ability of probiotic formulation for the control of prediabetes. Considering this background, the main objective of this research is to assess the effect of a new probiotic formulation on glycemic control, insulin resistance and the composition of the fecal microbiota in prediabetic subjects.

Start: March 2021

Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein

Diabetes is a major health concern in obese older Veterans, especially in those who are African American. The negative impact of diabetes on muscle and physical function contributes to metabolic as well as physical decline and is under-studied. This randomized controlled trial compares a higher-protein, weight loss regimen previously shown to improve physical function to an Recommended Dietary Allowance (RDA) protein intervention in obese older male Veterans with pre-diabetes and functional limitations. Equal numbers of white and black male Veterans will be studied, filling gaps in the investigators' knowledge of differential responses by race as well as obesity interventions for men in general. The primary outcome is functional performance by Short Physical Performance Battery and secondary measures include muscle quality, insulin sensitivity, lean body mass, physical activity, recent falls and fear of falling, instrumental activities of daily living, and quality of life measured at 0, 3 and 6 months. The goal of this research is to accelerate functional recovery and enhance independence in obese male Veterans, which is strongly aligned with the RR&D mission to "maximize the physical and social autonomy of Veterans".

Start: November 2019

Intermittent Fasting to Improve Insulin Secretion

Type 2 diabetes (T2D) mellitus is a challenge for health care systems as the numbers increases constantly. In 2014, 422 million people had been living with diabetes worldwide. The absolute numbers of people with prediabetes have also grown substantially over 25 years worldwide. In Germany, about 10% of the population has T2D and another 21 % of the population has prediabetes.Overall, 16% of all deaths in Germany are attributable to type 2 diabetes. Macro- and microvascular complications of diabetes imply a significant threat for the patients and are already present in the prediabetic state. Short term and long term complications, the burden of treatment, and reduced quality of life are major burdens of the disease. Accumulating data indicate that currently recommended therapeutic diet regimens in patients with obesity and diabetes are not sustainable on the long term. Novel concepts are therefore urgently needed. T2D occurs when insulin secretion from pancreatic beta-cells cannot sufficiently be increased to compensate for insulin resistance. Causes of beta-cell dysfunction are heterogeneous. In addition, the most important determinants of diabetes remission are the extend of weight loss and restoration of beta-cell function. In the course of diabetes progression, the inability to recover insulin secretion might identify the state of no return to normal glucose tolerance. It is therefore crucial to improve insulin secretion in treatment and prevention of diabetes. Up to now lifestyle intervention trials in prediabetes or pharmacological intervention trials in diabetes did not show improvement of insulin secretion after intervention. However, one recent small human trial shows that intermittent fasting (early time restricted fasting) is able to improve insulin secretion.Currently, there are no trials that examine the effect of intermittent fasting in individuals with a broad range of impaired glucose metabolism (from prediabetes to diabetes). Recently novel subtypes of diabetes and prediabetes with high risk for the early manifestation of diabetes complications have been identified. Currently, prevention strategies for this high risk individuals have not been examined yet. We will study for the first time the effectiveness of 4 weeks intermittent fasting on changes in insulin secretion capacity in subphenotypes of diabetes and in prediabetes.

Start: April 2021

TREAT to Improve Cardiometabolic Health

Over half of adult Americans have overweight or obesity, have prolonged daily eating duration into late hours and are at increased risk of developing type 2 diabetes, hypertension and cardiovascular diseases.There is an urgent need for easy-to-implement intervention to slow progression of chronic diseases in mid-life adults. The investigators propose to test the effect of a life style intervention, delivered via a smartphone application, to restrict the eating window to only 10 hours/day, or time restricted eating (TRE), in metabolically unhealthy adults who eat habitually for more than 14 hours a day. The investigators hypothesize that eating for a shorter window of time will result in weight loss, improve sleep and metabolism, and decrease cardiovascular risk burden.

Start: June 2021

Liver Fat as a Dietary Target for Treating Cardiometabolic Disorders in Prediabetes and Type 2 Diabetes

The overall aim of this study is to investigate the long-term impact of a customized diet aimed at reducing liver fat specifically and a healthy Nordic diet on ectopic fat (liver, pancreatic and visceral) and cardiometabolic risk in individuals with prediabetes and type 2 diabetes (T2D).

Start: September 2020

Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes

The investigators will conduct a single-arm mixed methods pilot study to examine the feasibility and acceptability of a low-carbohydrate diabetes prevention program (LC-DPP). The investigators will estimate weight loss as well as the percentage of participants who achieve 5% body weight loss at 6 month and 12 month timepoints. Weight loss from the pilot VA LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies and the VA MOVE! program. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 12-month study period. The investigators will also conduct qualitative interviews with participants at 6 and 12 months.

Start: October 2020

Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. The Behavioral Nudges for Diabetes Prevention (BEGIN) Trial will test two low-touch interventions designed to motivate adoption of these treatments to prevent diabetes. Given that 38% of U.S. adults have prediabetes, the proposed study has potential for large public health impact by testing pragmatic, scalable, and sustainable approaches based in primary care to promote evidence-based treatment for this common condition.

Start: July 2021

PreDM Clinical Decision Support Intervention

Clinical practice guidelines recommend intensive lifestyle interventions and metformin to prevent or delay type 2 diabetes; yet these treatments are not routinely used among the 86 million U.S. adults with prediabetes who may benefit from them. While clinical decision support (CDS) represents an effective approach for delivering guideline-based care, the potential of this strategy to improve diabetes prevention efforts has not been definitively tested. This study will develop the novel Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention and evaluate its impact on clinical outcomes, healthcare process measures, and associated costs.

Start: February 2020

Diabetes Risk Education and Communication Trial

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. This pilot study will develop and evaluate the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates information about diabetes risk and treatment options for preventing diabetes among primary care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project has large potential to impact public health by developing a scalable intervention to promote the use of evidence-based treatments that lower diabetes risk in this population.

Start: November 2017

Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors

One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted feeding; TRF) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRF also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRF can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRF depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRF' (eat between ~8 am-3 pm), (2) 'Mid-day TRF' (eat between ~1 pm - 8 pm), or (3) Control Schedule (~8 am - 8 pm) for 10 weeks. All food will be provided and matched between groups.

Start: August 2020

Technology-Supported Treatment of Sleep Apnea in Prediabetes

Despite the efficacy of intensive lifestyle interventions in prediabetes, the incidence of diabetes is rising, and thus there is a critical need for additional strategies to prevent diabetes and to reduce its cardiovascular complications in this high-risk population. Sleep apnea is a highly common condition in prediabetes, but it has been mostly ignored and undertreated in current practice. The proposed study will be the first to assess whether adding CPAP (continuous positive air pressure) treatment to a lifestyle intervention improves cardiometabolic outcomes beyond that achieved with lifestyle alone (i.e. current standard of care) in high-risk individuals with prediabetes.

Start: November 2020

The Effect of 360 Video and MAPS on Enrollment in the DPP

We will conduct a three-armed randomized, clinical trial to test the incremental effectiveness of Mobile 360° Video and Motivation and Problem Solving in motivating individuals with Prediabetes to enroll in the Diabetes Prevention Program. all participants will receive notification that they have Prediabetes and education about Prediabetes, Type 2 diabetes, and the Diabetes Prevention Program, some participants will receive the additional interventions

Start: February 2021

Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care

The purpose of this research is to understand the impact of medically tailored meals on health-related biometrics (e.g., glucose time-in-range, waist-hip ratio, cholesterol) and how providing medically tailored meals promotes engagement in diabetes education and drives information-seeking behavior.

Start: May 2021

Evaluation of a Telehealth DPP With Patients at the University of Mississippi Medical Center

The National Diabetes Prevention Program (DPP) is an evidence-based, 12-month lifestyle change program to prevent or delay the onset of type 2 diabetes mellitus (herein referred to as 'diabetes') among adults with prediabetes. The Department of Preventive Medicine, University of Mississippi Medical Center (UMMC), in partnership with the American Medical Association, is collaborating to develop and implement the DPP as a clinical service for UMMC patients beginning in September 2020. We aim to recruit 245 patients per year over 3 years. Because this is the first attempt to develop and implement the DPP as a clinical service at the UMMC, we are proposing to conduct a comprehensive process, outcome, impact and return on investment evaluation. An effectiveness-implementation hybrid research design will be used to (1) evaluate a multifaceted implementation strategy and the effectiveness and impact of the DPP delivered using telehealth by UMMC's Department of Preventive Medicine; (2) conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and return on investment (ROI) relative to non-participants; (3) conduct a longitudinal cohort analysis to assess incidence of diabetes and changes in body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not. The findings from this comprehensive research evaluation will be used to (1) improve clinical operations and implementation; (2) demonstrate the cost benefit of the DPP as a clinical service for patients with diabetes risk; and (3) provide empirical support for delivering the DPP via different modalities including telehealth to reduce risk and improve health outcomes among patients.

Start: February 2020

Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes

The aim of this study is to examine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with prediabetes. In addition, the study also aims to look at the effect of Metabolic Rheostat™ and Butyrate Ultra on weight, HgbA1c, fasting glucose, cholesterol, triglycerides, inflammation markers, and hormones.

Start: April 2021