Non-Response to Exercise

University Hospital Tuebingen40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Non-Responder

Interventions

exercise trainingBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Tübingen, Germany

Outcomes

Primary Outcomes

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

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

Time frame: 11 weeks

Secondary Outcomes

molecular mechanisms of non-response

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

Time frame: 11 weeks

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

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

Time frame: 11 weeks

inflammatory response to exercise

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

Time frame: 11 weeks

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

changes in brain insulin sensitivity, before and after the intervention

Time frame: 11 weeks

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

measured by MRI

Time frame: 11 weeks

identification of serum biomarkers of non-response

Time frame: 11 weeks

Data from ClinicalTrials.gov

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