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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03231839
Other study ID # UTubingen4
Secondary ID
Status Completed
Phase N/A
First received July 24, 2017
Last updated July 24, 2017
Start date February 1, 2009
Est. completion date July 31, 2016

Study information

Verified date July 2017
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date July 31, 2016
Est. primary completion date June 30, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Behavioral:
Caloric restriction
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
no red meat
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
Increased fiber intake
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).

Locations

Country Name City State
Germany University of Tuebingen Tuebingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in glucose metabolism glucose metabolism measured during the oral glucose tolerance test (OGTT) baseline and six months
Secondary Insulin secretion Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI)) baseline and six months
Secondary liver fat measured by magnetic resonance spectroscopy baseline and six months
Secondary liver iron content measured by magnetic resonance imaging baseline and six months
Secondary body composition measured by magnetic resonance imaging baseline and six months
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