Nutritional Prevention of Diabetes Mellitus Type 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-01

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study investigates the influence of red meat and fibers on glucose metabolism and body fat composition in subjects at increased risk for type 2 diabetes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes

NCT04509245

Type 2 Diabetes Fatty Liver, Nonalcoholic

COMPLETED NA

Diabetes Dietary Study- Low Carbohydrate and Low-Fat Diets in Type 2 Diabetes

NCT00795691

Type 2 Diabetes

COMPLETED NA

Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes

NCT05666843

Diabetes Mellitus, Type 2 Cardiovascular Diseases

COMPLETED NA

Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes

NCT02764021

Type 2 Diabetes Mellitus

COMPLETED NA

Effects of Novel Fiber on Glucose Metabolism and Insulin Sensitivity

NCT01375803

Insulin Resistance

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk factors for T2D is solid. However, few intervention studies have been performed in order to investigate the role of whole-grain intake or the consumption of red meat in glycemic control and prevention of diabetes, yielding contradicting results. Thus, in order to prove causality, further identify potential underlying mechanisms and be able to improve lifestyle modification programs, we performed a randomized, controlled intervention study over six months. The participants are individuals at increased risk for tyoe 2 diabetes. They were randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group), 2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose tolerance tests, and MRI measurements of body fat composition and iron content in the liver. In this study, we want to compare the effectiveness of reduced caloric intake only versus reduced caloric intake with an additional modification of diet composition in terms of red meat and fiber consumption.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus Nutritional and Metabolic Diseases Liver Fat Insulin Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Caloric restriction (control)

daily reduction of caloric intake aimed at 400 kcal/day

Group Type PLACEBO_COMPARATOR