Exercise and GLP-1 RA on Insulin Secretion

NCT ID: NCT04383197

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The effects of endurance exercise alone or in addition to treatment with glucagon-like- peptide receptor agonists on insulin secretory capacity, will be determined in patients with type 2 diabetes.

Included patients will be randomized to either 12 weeks of endurance exercise training 3 times a week or therapeutical treatment with semaglutide for 3 months followed by 12 weeks of endurance exercise training 3 times a week. Insulin secretory capacity will be determined by hyperglycemic clamp method before and after.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Semaglutide treatment

3 months of therapeutic semaglutide treatment

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

3 months of therapeutic treatment with semaglutide

Semaglutide and Endurance exercise

12 weeks of endurance exercise concomitant to semaglutide treatment

Group Type EXPERIMENTAL

Endurance exercise training

Intervention Type BEHAVIORAL

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

Semaglutide

Intervention Type DRUG

3 months of therapeutic treatment with semaglutide

Endurance exercise

12 weeks of endurance exercise

Group Type EXPERIMENTAL

Endurance exercise training

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endurance exercise training

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

Intervention Type BEHAVIORAL

Semaglutide

3 months of therapeutic treatment with semaglutide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Flemming Dela

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Flemming Dela

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Copenhagen, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Arthur Ingersen, MD

Role: CONTACT

+45 60172697

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Arthur Ingersen, MD

Role: primary

+45 60 17 26 97

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37265222 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-19008233

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Semaglutide Treatment in Type 1 Diabetes
NCT06909006 NOT_YET_RECRUITING PHASE3
Liraglutide in Type 1 Diabetes
NCT01612468 COMPLETED PHASE4