Nutritional Prevention of Diabetes Mellitus Type 2 (NUPREDM)

University Hospital Tuebingen

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Liver Fat; Insulin Sensitivity; Nutritional and Metabolic Diseases

Treatments: Behavioral: Increased fiber intake; Behavioral: Caloric restriction; Behavioral: no red meat

Study type: Interventional

Funder types: Other

Identifiers

NCT03231839

UTubingen4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

132 participants in 3 patient groups, including a placebo group

Caloric restriction (control)

Placebo Comparator group

Description:

daily reduction of caloric intake aimed at 400 kcal/day

Treatment:

Behavioral: Caloric restriction

No red meat

Active Comparator group

Description:

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

Treatment:

Behavioral: no red meat

Increased fiber intake

Active Comparator group

Description:

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

Treatment:

Behavioral: Increased fiber intake