NCT03151590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

May 9, 2017

Last Update Submit

May 6, 2020

Conditions

Non-Responder

Outcome Measures

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

    11 weeks

Secondary Outcomes (6)

  • molecular mechanisms of non-response

    11 weeks

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

    11 weeks

  • inflammatory response to exercise

    11 weeks

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

    11 weeks

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

    11 weeks

  • +1 more secondary outcomes

Interventions

exercise trainingBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tübingen, 72076, Germany

Location

Related Publications (2)

  • 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.

    PMID: 36134657DERIVED

  • 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.

    PMID: 32827042DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hans-Ulrich Häring, Prof.

    University Hospital Tuebingen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. (MD)

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 12, 2017

Study Start

January 9, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)