Nutritional Prevention of Diabetes Mellitus Type 2

Not Applicable

Completed

• Conditions: Liver Fat; Nutritional and Metabolic Diseases; Insulin Sensitivity; Type 2 Diabetes Mellitus
• Interventions: Behavioral: no red meat; Behavioral: Caloric restriction; Behavioral: Increased fiber intake

• Registration Number: NCT03231839
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-02-01
• Primary Completion: 2012-06-30
• Study Completion: 2016-07-31
• Status Verified: 2017-07
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-24
• Last Update Submitted: 2017-07-24
• Study First Posted: 2017-07-27
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Individuals at a high risk for Type 2 diabetes:

• positive family history of type 2 diabetes,
• presence of metabolic syndrome,
• body mass index (BMI) > 27 kg/m2,
• diagnosis of impaired glucose tolerance (IGT)
• previous diagnosis of gestational diabetes diabetes

Exclusion Criteria

Main exclusion criteria

• diagnosis of type 1 or 2 diabetes mellitus
• BMI >45 kg/m²
• presence of serious illness such as cardiovascular, malignant or psychiatric disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No red meat	no red meat	daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake
Caloric restriction (control)	Caloric restriction	daily reduction of caloric intake aimed at 400 kcal/day
Increased fiber intake	Increased fiber intake	daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)

Primary Outcome Measures

Name	Time	Method
change in glucose metabolism	baseline and six months	glucose metabolism measured during the oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Name	Time	Method
Insulin secretion	baseline and six months	Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI))
liver fat	baseline and six months	measured by magnetic resonance spectroscopy
body composition	baseline and six months	measured by magnetic resonance imaging
liver iron content	baseline and six months	measured by magnetic resonance imaging

Trial Locations

Locations (1)

University of Tuebingen; 🇩🇪 Tuebingen, Germany