FGF-21 and Exercise in Relation to Insulin Secretion

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02667964
• Other study ID #: FGF-Exercise
• Status: Recruiting
• Phase: N/A
• First received: November 24, 2015
• Last updated: January 26, 2016
• Start date: November 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2016
• Source: Charite University, Berlin, Germany
• Contact: Thomas Bobbert, Dr.
• Phone: 450514252
• Email: thomas.bobbert[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Physical Activity

Intervention

Other:
• spiroergometry
Spiroergometry on a bicycle ergometer

Locations

Country	Name	City	State
Germany	Charité	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FGF-21 change after physical activity		FGF-21 before and 1 h after spiroergometry	No