FGF-21 and Exercise in Relation to Insulin Secretion

January 26, 2016 updated by: Knut Mai, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy controls
Spiroergometry
Other: spiroergometry
Spiroergometry on a bicycle ergometer
Other: Patients with T2DM
Spiroergometry
Other: spiroergometry
Spiroergometry on a bicycle ergometer
Other: Patients with T1DM
Spiroergometry
Other: spiroergometry
Spiroergometry on a bicycle ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FGF-21 change after physical activity
Time Frame: FGF-21 before and 1 h after spiroergometry
FGF-21 before and 1 h after spiroergometry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Thomas Bobbert, Dr, Charite

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • FGF-Exercise

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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