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Nutritional Prevention of Diabetes Mellitus Type 2 (NUPREDM)

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ClinicalTrials.gov Identifier: NCT03231839
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
andreas fritsche, University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE July 24, 2017
First Posted Date  ICMJE July 27, 2017
Last Update Posted Date July 27, 2017
Actual Study Start Date  ICMJE February 1, 2009
Actual Primary Completion Date June 30, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
change in glucose metabolism [ Time Frame: baseline and six months ]
glucose metabolism measured during the oral glucose tolerance test (OGTT)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • Insulin secretion [ Time Frame: baseline and six months ]
    Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI))
  • liver fat [ Time Frame: baseline and six months ]
    measured by magnetic resonance spectroscopy
  • liver iron content [ Time Frame: baseline and six months ]
    measured by magnetic resonance imaging
  • body composition [ Time Frame: baseline and six months ]
    measured by magnetic resonance imaging
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutritional Prevention of Diabetes Mellitus Type 2
Official Title  ICMJE Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Nutritional and Metabolic Diseases
  • Liver Fat
  • Insulin Sensitivity
Intervention  ICMJE
  • 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).
  • Behavioral: 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).
  • Behavioral: 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).
Study Arms  ICMJE
  • Placebo Comparator: Caloric restriction (control)
    daily reduction of caloric intake aimed at 400 kcal/day
    Intervention: Behavioral: Caloric restriction
  • Active Comparator: No red meat
    daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake
    Intervention: Behavioral: no red meat
  • Active Comparator: Increased fiber intake
    daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)
    Intervention: Behavioral: Increased fiber intake
Publications * Willmann C, Heni M, Linder K, Wagner R, Stefan N, Machann J, Schulze MB, Joost HG, Häring 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2017)
132
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2016
Actual Primary Completion Date June 30, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03231839
Other Study ID Numbers  ICMJE UTubingen4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not allowed by ethics committee
Responsible Party andreas fritsche, University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Tuebingen
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP