Nutritional Prevention of Diabetes Mellitus Type 2 (NUPREDM)
Primary Purpose
Type 2 Diabetes Mellitus, Nutritional and Metabolic Diseases, Liver Fat
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Caloric restriction
no red meat
Increased fiber intake
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus
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.
Sites / Locations
- University of Tuebingen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Caloric restriction (control)
No red meat
Increased fiber intake
Arm Description
daily reduction of caloric intake aimed at 400 kcal/day
daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake
daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)
Outcomes
Primary Outcome Measures
change in glucose metabolism
glucose metabolism measured during the oral glucose tolerance test (OGTT)
Secondary Outcome Measures
Insulin secretion
Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI))
liver fat
measured by magnetic resonance spectroscopy
liver iron content
measured by magnetic resonance imaging
body composition
measured by magnetic resonance imaging
Full Information
NCT ID
NCT03231839
First Posted
July 24, 2017
Last Updated
July 24, 2017
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03231839
Brief Title
Nutritional Prevention of Diabetes Mellitus Type 2
Acronym
NUPREDM
Official Title
Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2009 (Actual)
Primary Completion Date
June 30, 2012 (Actual)
Study Completion Date
July 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Nutritional and Metabolic Diseases, Liver Fat, Insulin Sensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caloric restriction (control)
Arm Type
Placebo Comparator
Arm Description
daily reduction of caloric intake aimed at 400 kcal/day
Arm Title
No red meat
Arm Type
Active Comparator
Arm Description
daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake
Arm Title
Increased fiber intake
Arm Type
Active Comparator
Arm Description
daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)
Intervention Type
Behavioral
Intervention Name(s)
Caloric restriction
Intervention Description
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
Intervention Type
Behavioral
Intervention Name(s)
no red meat
Intervention Description
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
Intervention Type
Behavioral
Intervention Name(s)
Increased fiber intake
Intervention Description
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
Primary Outcome Measure Information:
Title
change in glucose metabolism
Description
glucose metabolism measured during the oral glucose tolerance test (OGTT)
Time Frame
baseline and six months
Secondary Outcome Measure Information:
Title
Insulin secretion
Description
Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI))
Time Frame
baseline and six months
Title
liver fat
Description
measured by magnetic resonance spectroscopy
Time Frame
baseline and six months
Title
liver iron content
Description
measured by magnetic resonance imaging
Time Frame
baseline and six months
Title
body composition
Description
measured by magnetic resonance imaging
Time Frame
baseline and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72074
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not allowed by ethics committee
Citations:
PubMed Identifier
30721948
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.
Results Reference
derived
Learn more about this trial
Nutritional Prevention of Diabetes Mellitus Type 2
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