Nutritional Prevention of Diabetes Mellitus Type 2

Type 2 Diabetes Mellitus Clinical Trial

— NUPREDM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231839
• Other study ID #: UTubingen4
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Insulin Sensitivity
• Liver Fat
• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Type 2 Diabetes Mellitus

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