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Completed

NCT Number: NCT03151590

Non-Response to Exercise

The purpose of this prospective intervention study is to find biomarkers and underlying pathomechanisms for non-response of improvement in glucose metabolism to exercise.

An additional goal is to identify non-responders at an early stage, where prevention strategies (pharmacologically or by specific training) will be successful.

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Key information

Conditions

Non-Responder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Diabetes research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen

Tübingen, 72076, Germany

About this study

At baseline and end of study, an intensive metabolic phenotyping including cerebral insulin sensitivity as well as tissue biopsies are performed in overweight untrained healthy participants at high risk for type 2 diabetes. During the study, an individual exercise training at 80% VO2max is performed for 9 weeks. Before and after the training intervention, acute tissue biopsies after a standardized bout of exercise are obtained.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • at least one of the following risk factors for type 2 diabetes:
  • overweight (BMI>27 kg/m2)
  • impaired fasting glucose and/ or glucose tolerance
  • former gestational diabetes
  • family history for type 2 diabetes (first-degree relative)
  • sedentary participant (< 2 exercise bouts/week)

Exclusion criteria

  • any kind of metal in or on the body
  • thermosensory or heightened sensitivity to heating
  • heightened sensitivity to loud noise or diseases of the ear
  • claustrophobia
  • Diabetes mellitus
  • current pregnancy or breastfeeding
  • cardiovascular diseases
  • surgery, < 3 months ago
  • participation in other clinical trials
  • acute illness/infection, < 4 weeks ago
  • severe mental illness
  • hemoglobin, women < 11g/dl, men < 13g/dl
  • potentially incompliant subjects and/or inability to absolve the exercise training
  • glucose influencing drugs
  • continuous analgetic drugs
  • use of anticoagulants

Treatment and study plan

Exercise Training

Behavioral

Primary outcomes

  1. exercise response with respect to changes in insulin sensitivity from baseline to post-intervention measurement

    Time frame: 11 weeks

    insulin sensitivity is measured before and after the training intervention by a 5-point-75g-OGTT and calculated by ISI Matsuda

Secondary outcomes

  1. molecular mechanisms of non-response

    Time frame: 11 weeks

    molecular mechanisms of non-response in insulin sensitivity in peripheral insulin target tissues (skeletal muscle, adipose tissue)

  2. differences in the adaptation process to exercise in responders versus non-responders

    Time frame: 11 weeks

    by assessing the acute inflammatory response in blood samples and tissue biopsies obtained directly after an acute bout of exercise, at the beginning, and the end of the exercise intervention

  3. inflammatory response to exercise

    Time frame: 11 weeks

    local (muscle and fat) versus systemic (blood) inflammatory response to exercise

  4. changes in brain insulin sensitivity by exercise, and brain differences in responders vs. non-responders

    Time frame: 11 weeks

    changes in brain insulin sensitivity, before and after the intervention

  5. role of visceral fat mass in determining the non-response of insulin sensitivity to exercise

    Time frame: 11 weeks

    measured by MRI

  6. identification of serum biomarkers of non-response

    Time frame: 11 weeks

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Non-Response to Exercise - Identification of Factors Contributing to Exercise Non-response.

Acronym: NRE2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 12, 2017
Registry last updated
May 8, 2020

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.