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FGF-21 and Exercise in Relation to Insulin Secretion

NCT ID: NCT02667964

Last Updated: 2016-01-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-06-30

Brief Summary

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FGF-21 and insulin are key hormones in the regulation of glucose metabolism. Furthermore, both hormones are influenced by physical activity. The following hypothesis will be tested: FGF-21 is regulated insulin-dependent during exercise.

Detailed Description

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Type 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by rising global importance. In Germany alone, more than seven million people are being treated currently. T2DM is characterized by permanently elevated blood glucose levels, based on insulin resistance and followed by associated beta cell failure. In our previous work the investigators could already shown that increased FGF-21 levels are accompanied by an increased risk of T2DM. Physical activity is essential in the treatment and the prevention of T2DM. Interestingly, it was shown that acute physical exercise was leading to decreased insulin levels and increased FGF-21 values. In this study the effects of acute physical activity on FGF-21 values should be investigated in 3 groups: a) Healthy volunteers b) persons with T2DM c) persons with T1DM.

Conditions

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Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy controls

Spiroergometry

Group Type OTHER

spiroergometry

Intervention Type OTHER

Spiroergometry on a bicycle ergometer

Patients with T2DM

Spiroergometry

Group Type OTHER

spiroergometry

Intervention Type OTHER

Spiroergometry on a bicycle ergometer

Patients with T1DM

Spiroergometry

Group Type OTHER

spiroergometry

Intervention Type OTHER

Spiroergometry on a bicycle ergometer

Interventions

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spiroergometry

Spiroergometry on a bicycle ergometer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers,persons with T2DM, persons with T1DM

Exclusion Criteria

* Patients with contraindications to an exercise ECG or spirometry be excluded from participation in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Knut Mai

FGF-21 and Exercise

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Bobbert, Dr

Role: PRINCIPAL_INVESTIGATOR

Charité

Locations

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Charité

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thomas Bobbert, Dr.

Role: CONTACT

Phone: 450514252

Email: [email protected]

Facility Contacts

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Thomas Bobbert, Dr.

Role: primary

Other Identifiers

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FGF-Exercise

Identifier Type: -

Identifier Source: org_study_id