FGF-21 and Exercise in Relation to Insulin Secretion

Not Applicable

• Conditions: Physical Activity
• Interventions: Other: spiroergometry

• Registration Number: NCT02667964
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-24
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Study First Posted: 2016-01-29
• Last Update Posted: 2016-01-29
• Primary Completion: 2016-11
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	spiroergometry	Spiroergometry
Patients with T2DM	spiroergometry	Spiroergometry
Patients with T1DM	spiroergometry	Spiroergometry

Primary Outcome Measures

Name	Time	Method
FGF-21 change after physical activity	FGF-21 before and 1 h after spiroergometry

Trial Locations

Locations (1)

Charité; 🇩🇪 Berlin, Germany