Non-Response to Exercise

NCT ID: NCT03151590

Last Updated: 2020-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Non-Responder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Anja Boehm

Dr. med. (MD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans-Ulrich Häring, Prof.

Role: STUDY_DIRECTOR

University Hospital Tuebingen

Locations

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

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 36134657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32827042 (View on PubMed)

Other Identifiers

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446/2016BO2

Identifier Type: -

Identifier Source: org_study_id

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