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Completed

NCT Number: NCT03231839

Nutritional Prevention of Diabetes Mellitus Type 2

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tuebingen

Tübingen, 72074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caloric restriction

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. change in glucose metabolism

    Time frame: baseline and six months

    glucose metabolism measured during the oral glucose tolerance test (OGTT)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: NUPREDM

Important dates

Study start
2009
Primary completion
2012
Study completion
2016
First posted
Jul 27, 2017
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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