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CompletedNCT03151590NRE2Updated May 8, 2020

Non-Response to Exercise

An interventional study of exercise training in Non-Responder, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-08.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2017, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-Responder
03

In context

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.

Browse University Hospital Tuebingen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Interventions

  • Behavioralexercise training
06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. inflammatory response to exercise

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

    Time frame: 11 weeks

  4. 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

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

    measured by MRI

    Time frame: 11 weeks

  6. identification of serum biomarkers of non-response

    Time frame: 11 weeks

07

Study locations

1 site
  • Institute for Diabetes research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tübingen
    Tübingen, 72076, Germany
08

References and documents

Publications

  • 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. PubMed 36134657 ↗
  • 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. PubMed 32827042 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Dec 2018, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2017
First posted
May 12, 2017
StartActual
Jan 9, 2017
Primary completionActual
Dec 31, 2018
CompletionActual
Dec 31, 2018
Last update
May 8, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03151590
Lead sponsor
University Hospital Tuebingen
Responsible party
Dr. Anja Boehm (Dr. med. (MD), University Hospital Tuebingen) — Principal investigator
First posted
May 12, 2017
Start date
Jan 9, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
May 8, 2020

Study contacts

Hans-Ulrich Häring, Prof.
study director · University Hospital Tuebingen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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