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Exercise and GLP-1 RA on Insulin Secretion

Effects of 12 Weeks of Endurance Exercise Training Alone or in Combination With Glucagon Like Peptide 1 Receptor Agonist (GLP-1 RA) Treatment on Insulin Secretory Capacity in Type 2 Diabetes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04383197
Acronym
EXISECRET
Enrollment
30
Registered
2020-05-12
Start date
2019-12-10
Completion date
2022-08-31
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Insulin secretion, Beta cell function

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.

Detailed description

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.

Interventions

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

DRUGSemaglutide

3 months of therapeutic treatment with semaglutide

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Insulin secretionChange from baseline insulin secretion after Exercise intervention(12 weeks).By hyperglycemic clamp

Secondary

MeasureTime frameDescription
insulin sensitivityBefore and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatmentDerived from hyperglycemic clamp and HOMA-IR
Changes in plasma bone markersBefore and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatmentChanges in baseline CTX, PNIP, Osteocalcin and alkaline phosphatase
Insulin secretionBefore and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatmentBy Oral glucose tolerance test
Cardiorespiratory fitnessBefore and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatmentChanges in maximal oxygen uptake
Body compositionBefore and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatmentBy DXA
Glucose homeostasisBefore and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatmentChanges in HbA1c

Countries

Denmark

Contacts

Primary ContactArthur Ingersen, MD
hansai@sund.ku.dk+45 60172697

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026