Clinical trial NCT03151590: Non-Response to Exercise
Official title: Non-Response to Exercise - Identification of Factors Contributing to Exercise Non-response.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Responder
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: exercise response with respect to changes in insulin sensitivity from baseline to post-intervention measurement
timeFrame: 11 weeks
Secondary outcomes:
measure: molecular mechanisms of non-response
timeFrame: 11 weeks
measure: differences in the adaptation process to exercise in responders versus non-responders
timeFrame: 11 weeks
measure: inflammatory response to exercise
timeFrame: 11 weeks
measure: changes in brain insulin sensitivity by exercise, and brain differences in responders vs. non-responders
timeFrame: 11 weeks
measure: role of visceral fat mass in determining the non-response of insulin sensitivity to exercise
timeFrame: 11 weeks
measure: identification of serum biomarkers of non-response
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Institute for Diabetes research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen
Study officials:
affiliation: University Hospital Tuebingen
name: Hans-Ulrich Häring, Prof.
role: STUDY_DIRECTOR
References:
citation: Kullmann S, Goj T, Veit R, Fritsche L, Wagner L, Schneeweiss P, Hoene M, Hoffmann C, Machann J, Niess A, Preissl H, Birkenfeld AL, Peter A, Haring HU, Fritsche A, Moller A, Weigert C, Heni M. Exercise restores brain insulin sensitivity in sedentary adults who are overweight and obese. JCI Insight. 2022 Sep 22;7(18):e161498. doi: 10.1172/jci.insight.161498.
citation: Hoffmann C, Schneeweiss P, Randrianarisoa E, Schnauder G, Kappler L, Machann J, Schick F, Fritsche A, Heni M, Birkenfeld A, Niess AM, Haring HU, Weigert C, Moller A. Response of Mitochondrial Respiration in Adipose Tissue and Muscle to 8 Weeks of Endurance Exercise in Obese Subjects. J Clin Endocrinol Metab. 2020 Nov 1;105(11):dgaa571. doi: 10.1210/clinem/dgaa571.