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Clinical Trials/NCT03231839
NCT03231839CompletedNot Applicable

Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes

University Hospital Tuebingen1 site in 1 country132 target enrollmentStarted: February 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
132
Locations
1
Primary Endpoint
change in glucose metabolism

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Caloric restriction (control)

Placebo Comparator

daily reduction of caloric intake aimed at 400 kcal/day

Intervention: Caloric restriction (Behavioral)

No red meat

Active Comparator

daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake

Intervention: no red meat (Behavioral)

Increased fiber intake

Active Comparator

daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)

Intervention: Increased fiber intake (Behavioral)

Outcomes

Primary Outcomes

change in glucose metabolism

Time Frame: baseline and six months

glucose metabolism measured during the oral glucose tolerance test (OGTT)

Secondary Outcomes

  • Insulin secretion(baseline and six months)
  • liver fat(baseline and six months)
  • body composition(baseline and six months)
  • liver iron content(baseline and six months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

andreas fritsche

Professor

University Hospital Tuebingen

Study Sites (1)

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