FGF-21 During Physical Exercise in Patients With Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus and Healthy Controls

FGF-21 and Exercise in Relation to Insulin Secretion


Lead sponsor: Charite University, Berlin, Germany

Source 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.

Overall Status Unknown status
Start Date November 2015
Completion Date June 2017
Primary Completion Date November 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
FGF-21 change after physical activity FGF-21 before and 1 h after spiroergometry
Enrollment 60

Intervention type: Other

Intervention name: spiroergometry

Description: Spiroergometry on a bicycle ergometer



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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thomas Bobbert, Dr Principal Investigator Charité
Overall Contact

Last name: Thomas Bobbert, Dr.

Phone: 450514252

Phone ext: 030

Email: [email protected]

facility status contact Charité Thomas Bobbert, Dr. 450514252 030 [email protected]
Location Countries


Verification Date

January 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Charite University, Berlin, Germany

Investigator full name: Knut Mai

Investigator title: FGF-21 and Exercise

Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: Healthy controls

Arm group type: Other

Description: Spiroergometry

Arm group label: Patients with T2DM

Arm group type: Other

Description: Spiroergometry

Arm group label: Patients with T1DM

Arm group type: Other

Description: Spiroergometry

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov