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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
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

First Posted
July 24, 2017
Last Updated
July 24, 2017
Sponsor
University Hospital Tuebingen
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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

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Nutritional Prevention of Diabetes Mellitus Type 2

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