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Prediabetes clinical trials

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NCT ID: NCT05035966 Completed - PreDiabetes Clinical Trials

Association of β-amyloid 40 and 42 With Prediabetes

Start date: January 1, 2012
Phase:
Study type: Observational

Background: Previous epidemiological and animal studies have suggested a strong relationship between prediabetes and Alzheimer's disease. Recently, we demonstrated that plasma β-amyloid (Aβ), a potential biomarker for Alzheimer's disease, was elevated in individuals with type 2 diabetes. However, few studies have investigated the associations of plasma Aβ40 and Aβ42 concentrations with prediabetes. Objective: we aimed to investigate the associations of plasma Aβ40 and Aβ42 concentrations with risk of prediabetes in two independent studies. Design: We performed a case-control study and a nested case-control study within a prospective cohort study. In the case-control study, we included 571 newly diagnosed individuals with prediabetes and 571 control participants. Prediabetes individuals were consecutively recruited from subjects who attended the outpatient clinics of Department of Endocrinology at Tongji Medical College Hospital from 2012 to 2015. Concomitantly, we recruited healthy controls from a general population undergoing a routine health checkup in the same hospital. One healthy control was selected at random for each prediabetes individuals according to age (±3 years) and sex. The inclusion criteria of participants were as follows: age ≥30 and ≤80 years, BMI <40 kg/m2, no history of prediabetes and diabetes mellitus, no history of receiving pharmacological treatment for hyperlipidemia, nor any clinically systemic disease, any acute illness, and chronic inflammatory or any infective disease. An independent nested case-control study was conducted within an ongoing cohort study, namely the Tongji-Ezhou cohort. Briefly, 5533 participants, including 3101 retired employees and 2432 working employees, were enrolled from Echeng Stell and received healthcare for a baseline investigation between 2013 and 2015. The first follow-up for all participants was finished by mid-2020. Considering the low incidence of prediabetes among young working employees, we performed the nested case-control study among retired employees. During the follow-up, 119 new-onset prediabetes cases were diagnosed within the retired employees according to fasting plasma glucose. We randomly selected the control participants who matched 2:1 to the cases by age (±3 years) and sex from the retired employees with normal fasting plasma glucose. The inclusion criteria were the same as the case-control study; 2 new-onset prediabetes cases aged >80 years were excluded. Additionally, 17 cases without enough plasma were excluded. Finally, 100 individuals with new-onset prediabetes and 200 well-matched control participants were included for the analysis of the nested case-control study. These two studies were approved by the Ethics and Human Subject Committee of Tongji Medical College. All enrolled participants in the two studies were of Chinese Han ethnicity and provided informed written consent. Plasma Aβ40 and Aβ42 concentrations were simultaneously measured by validated assay platforms from Meso Scale Discovery (MSD; Rockville, MD, USA).

NCT ID: NCT04994327 Completed - PreDiabetes Clinical Trials

Bread Replacement - Facing the Challenge to Improve Its Quality for Better Metabolic Health

Start date: May 7, 2021
Phase: N/A
Study type: Interventional

This is a multicenter study testing the effect of bread containing beta-glucan on glycemic control in participants with intermediate hyperglycemia. The main hypothesis of the study is that bread enriched with beta-glucan will have a positive effect on blood glucose control (HbA1c) in persons with intermediate hyperglycemia. Bread (intervention and control) will be produced by Nofima (Ås, Norway) using food-grade beta-glucan from oat and barley and shipped to the study centers (Bergen (N), Gothenburg (S), Paderborn, and Leipzig (D)) and there distributed for free to the participants of the study. The study will last for 16 weeks with measurements at baseline, after 8 weeks and after 16 weeks. Blood and urine samples will be taken, anthropometry and body composition measured, and questionnaires on health status and socio-economic status, physical activity, nicotine use, alcohol habits, chronotype, quality of life, and consumer acceptance of the study bread will be filled in.

NCT ID: NCT04949958 Completed - PreDiabetes Clinical Trials

Effects of Exercise Based Manual in Sedentary Prediabetic Population

Start date: April 15, 2022
Phase: N/A
Study type: Interventional

The prediabetes is a state in which fasting blood glucose level ranges between 100-126mg/dl or HbA1C ranges between 5.7-6.4mmol. People with prediabetes have 74 percent chance of progression to develop Type 2 diabetes mellitus. However, by lifestyle intervention, Type 2 Diabetes mellitus may be effectively avoided or delayed. The improvement in lifestyle is involving the physical activity of at least 150mins per week lowered the rate of T2DM in people with prediabetes by 58 percent. There are several risk factors for the development of type 2 diabetes mellitus, but obesity and lack of physical activity are major risk factors that cause type 2 diabetes mellitus in prediabetic populations. Diet and exercise are the first line treatment for sedentary prediabetics. Both independent and combined effect of diet and exercise can reduce the incidence of T2DM, glycemic control and weight loss in adults with prediabetics

NCT ID: NCT04931836 Completed - Obesity Clinical Trials

The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults

Start date: July 29, 2021
Phase: N/A
Study type: Interventional

The present study is a 100-participant randomized controlled 2-arm parallel trial that employs a metagenomic approach to examine how 8 weeks of supervised moderate-intensity treadmill walking exercise (MWE) for 30-45 min 3 times/week alters the gut microbiome, serum short chain fatty acids, and the cardiometabolic profile, body weight, and body composition of individuals 30-64 years old who have overweight or obesity and have prediabetes.

NCT ID: NCT04927871 Completed - Obesity Clinical Trials

Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela

HITS
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

The American Diabetes Association recommends implementing the Diabetes Prevention Program (DPP) in subjects with prediabetes. In the DPP, weight reduction was the main predictor of a lower incidence of type 2 diabetes (T2D), each kilogram lost was related with 16% lower incidence. However, the effectiveness of the DPP in primary care settings is lower than the original study. A meta-analysis of 36 pragmatic clinical trials of DPP in primary care settings showed a reduction in T2D incidence by 26%, less than half than the original study (58%), with a pooled mean weight loss 1.57 kg higher than standard care, demonstrating the large difficulties to reduce weight of participants at community levels. Total diet replacement (TDR) with low-energy liquid-diet or solid diet (825-853 kcal/day) is an effective strategy to reduce weight. The effectiveness of an intervention including initial rapid weight loss before starting the DPP is ignored in primary care levels in Venezuela. We aim: 1- To compare the weight loss achieved of two lifestyle intervention programs in a community health center of Venezuela: a) A hybrid lifestyle including rapid weight loss with total diet replacement (TDR), then medical nutrition therapy (MNT), and the DPP, VS b) only the DPP; 2- To evaluate the change of cardiometabolic risk factors between groups; 3- To evaluate the implementation process. Our hypothesis is: after six months of intervention, subjects receiving a hybridized lifestyle (TDR+MNT+DPP) will double the weight loss of those that only receive DPP.

NCT ID: NCT04881890 Completed - PreDiabetes Clinical Trials

Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes

VA LC-DPP
Start date: October 5, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04863313 Completed - Clinical trials for Overweight and Obesity

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

PREDIABETCAR
Start date: March 11, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04835636 Completed - PreDiabetes Clinical Trials

Modified Diabetes Prevention Program in Ecuador

Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador.

NCT ID: NCT04824209 Completed - Insulin Resistance Clinical Trials

Serum Pro-Diabetes Inflammation Biomarkers in Patients With Apical Periodontitis.

Start date: February 9, 2021
Phase:
Study type: Observational [Patient Registry]

Inflammation is a common factor of chronic periodontitis and diabetes. However, to date, there is no scientific evidence supporting a causal effect of the inflammation created by apical periodontitis on the onset of insulin resistance and on metabolic derangement in the condition of pre-diabetes or diabetes. A case control study has been designed in order to evaluate serum levels of pro-diabetes inflammation factors in a sample of healthy patients between 25 and 55 years of age, with or without apical periodontitis,before endodontic treatment and at 6 and 12 months post-treatment. The aim of the study is to evaluate any relation between the presence of chronic endodontic lesions and pro-diabetes inflammation factors that can promote the onset of insulin resistance, and whether endodontic treatment can reduce these factors, thus preventing a pro-diabetes status.

NCT ID: NCT04810026 Completed - Clinical trials for Diabetes Mellitus, Type 2

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

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

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.