Clinical trial NCT03231839: Nutritional Prevention of Diabetes Mellitus Type 2
Official title: Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Nutritional and Metabolic Diseases
Liver Fat
Insulin Sensitivity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in glucose metabolism
timeFrame: baseline and six months
Secondary outcomes:
measure: Insulin secretion
timeFrame: baseline and six months
measure: liver fat
timeFrame: baseline and six months
measure: liver iron content
timeFrame: baseline and six months
measure: body composition
timeFrame: baseline and six months
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University of Tuebingen
Study officials:
References:
citation: 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.