NCT02667964

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

November 24, 2015

Last Update Submit

January 26, 2016

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

  • FGF-21 change after physical activity

    FGF-21 before and 1 h after spiroergometry

Study Arms (3)

Healthy controls

OTHER

Spiroergometry

Other: spiroergometry

Patients with T2DM

OTHER

Spiroergometry

Other: spiroergometry

Patients with T1DM

OTHER

Spiroergometry

Other: spiroergometry

Interventions

spiroergometryOTHER

Spiroergometry on a bicycle ergometer

Healthy controlsPatients with T1DMPatients with T2DM

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers,persons with T2DM, persons with T1DM

You may not qualify if:

  • Patients with contraindications to an exercise ECG or spirometry be excluded from participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, State of Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Thomas Bobbert, Dr

    Charité

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Bobbert, Dr.

CONTACT

450514252thomas.bobbert@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FGF-21 and Exercise

Study Record Dates

First Submitted

November 24, 2015

First Posted

January 29, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

June 1, 2017

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

DE(1)