Nutritional Prevention of Diabetes Mellitus Type 2 (NUPREDM)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72074
    • University of Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Caloric restriction (control); daily reduction of caloric intake aimed at 400 kcal/day	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).
Active Comparator: No red meat; daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake	Behavioral: 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).
Active Comparator: Increased fiber intake; daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in glucose metabolism	glucose metabolism measured during the oral glucose tolerance test (OGTT)	baseline and six months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Publications and helpful links

General Publications

• Willmann C, Heni M, Linder K, Wagner R, Stefan N, Machann J, Schulze MB, Joost HG, Haring HU, Fritsche A. Potential effects of reduced red meat compared with increased fiber intake on glucose metabolism and liver fat content: a randomized and controlled dietary intervention study. Am J Clin Nutr. 2019 Feb 1;109(2):288-296. doi: 10.1093/ajcn/nqy307.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): June 30, 2012
• Study Completion (Actual): July 31, 2016

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Diseases
• Other Study ID Numbers: UTubingen4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not allowed by ethics committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No