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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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Nutritional and Metabolic Diseases Liver Fat Insulin Sensitivity Behavioral: Caloric restriction Behavioral: no red meat Behavioral: Increased fiber intake Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes
Actual Study Start Date : February 1, 2009
Actual Primary Completion Date : June 30, 2012
Actual Study Completion Date : July 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Caloric restriction (control)
daily reduction of caloric intake aimed at 400 kcal/day
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).

Active Comparator: No red meat
daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake
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).

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




Primary Outcome Measures :
  1. change in glucose metabolism [ Time Frame: baseline and six months ]
    glucose metabolism measured during the oral glucose tolerance test (OGTT)


Secondary Outcome Measures :
  1. Insulin secretion [ Time Frame: baseline and six months ]
    Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI))

  2. liver fat [ Time Frame: baseline and six months ]
    measured by magnetic resonance spectroscopy

  3. liver iron content [ Time Frame: baseline and six months ]
    measured by magnetic resonance imaging

  4. body composition [ Time Frame: baseline and six months ]
    measured by magnetic resonance imaging



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231839


Locations
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Germany
University of Tuebingen
Tuebingen, Germany, 72074
Sponsors and Collaborators
University Hospital Tuebingen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: andreas fritsche, Professor, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03231839    
Other Study ID Numbers: UTubingen4
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not allowed by ethics committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Hyperinsulinism