NCT04383197

Brief Summary

The purpose of this study is to determine the effect of endurance exercise on insulin secretory capacity, alone or in addition to treatment with the glucagon-like-peptide receptor agonist semaglutide, in patients with type 2 diabetes.

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
30

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable type-2-diabetes

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

December 10, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

May 4, 2020

Last Update Submit

February 8, 2021

Conditions

Type 2 Diabetes

Keywords

Insulin secretionBeta cell function

Outcome Measures

Primary Outcomes (3)

  • Insulin secretion

    By hyperglycemic clamp

    Change from baseline insulin secretion after Exercise intervention(12 weeks).

  • Insulin secretion

    By hyperglycemic clamp

    Change from baseline insulin secretion after 3 months of therapeutic semaglutide treatment

  • Insulin secretion

    By hyperglycemic clamp

    Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment

Secondary Outcomes (6)

  • Insulin secretion

    Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

  • insulin sensitivity

    Before and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatment

  • Changes in plasma bone markers

    Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

  • Glucose homeostasis

    Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

  • Cardiorespiratory fitness

    Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

  • +1 more secondary outcomes

Study Arms (3)

Semaglutide treatment

EXPERIMENTAL

3 months of therapeutic semaglutide treatment

Drug: Semaglutide

Semaglutide and Endurance exercise

EXPERIMENTAL

12 weeks of endurance exercise concomitant to semaglutide treatment

Behavioral: Endurance exercise trainingDrug: Semaglutide

Endurance exercise

EXPERIMENTAL

12 weeks of endurance exercise

Behavioral: Endurance exercise training

Interventions

Endurance exercise trainingBEHAVIORAL

Ergometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week

Endurance exerciseSemaglutide and Endurance exercise
SemaglutideDRUG

3 months of therapeutic treatment with semaglutide

Semaglutide and Endurance exerciseSemaglutide treatment

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with type 2 diabetes
  • BMI 28-35
  • Moderately preserved insulin secretory capacity (determined by glucagon test)

You may not qualify if:

  • Insulin treatment
  • Hypertension grade 3
  • Heart disease
  • Medical history with pancreatitis
  • Diagnosed with neuropathy
  • Excessive alcohol consumption
  • Any condition that would interfere with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

RECRUITING

Related Publications (1)

  • Ingersen A, Schmucker M, Alexandersen C, Graungaard B, Thorngreen T, Borch J, Holst JJ, Helge JW, Dela F. Effects of Aerobic Training and Semaglutide Treatment on Pancreatic beta-Cell Secretory Function in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2023 Oct 18;108(11):2798-2811. doi: 10.1210/clinem/dgad326.

    PMID: 37265222DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Flemming Dela

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Ingersen, MD

CONTACT

+45 60172697hansai@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 12, 2020

Study Start

December 10, 2019

Primary Completion

August 1, 2021

Study Completion

August 1, 2022

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Can be provided upon reasonable request

Locations

DK(1)