Non-Response to Exercise

Not Applicable

Completed

• Conditions: Non-Responder

• Registration Number: NCT03151590
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-01-09
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
exercise response with respect to changes in insulin sensitivity from baseline to post-intervention measurement	11 weeks	insulin sensitivity is measured before and after the training intervention by a 5-point-75g-OGTT and calculated by ISI Matsuda

Secondary Outcome Measures

Name	Time	Method
role of visceral fat mass in determining the non-response of insulin sensitivity to exercise	11 weeks	measured by MRI
identification of serum biomarkers of non-response	11 weeks
differences in the adaptation process to exercise in responders versus non-responders	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
inflammatory response to exercise	11 weeks	local (muscle and fat) versus systemic (blood) inflammatory response to exercise
molecular mechanisms of non-response	11 weeks	molecular mechanisms of non-response in insulin sensitivity in peripheral insulin target tissues (skeletal muscle, adipose tissue)
changes in brain insulin sensitivity by exercise, and brain differences in responders vs. non-responders	11 weeks	changes in brain insulin sensitivity, before and after the intervention

Trial Locations

Locations (1)

Institute for Diabetes research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen; 🇩🇪 Tübingen, Germany