Exercise and GLP-1 RA on Insulin Secretion

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Endurance exercise training; Drug: Semaglutide

• Registration Number: NCT04383197
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-11
• Primary Completion: 2021-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide and Endurance exercise	Endurance exercise training	12 weeks of endurance exercise concomitant to semaglutide treatment
Endurance exercise	Endurance exercise training	12 weeks of endurance exercise
Semaglutide treatment	Semaglutide	3 months of therapeutic semaglutide treatment
Semaglutide and Endurance exercise	Semaglutide	12 weeks of endurance exercise concomitant to semaglutide treatment

Primary Outcome Measures

Name	Time	Method
Insulin secretion	Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment	By hyperglycemic clamp

Secondary Outcome Measures

Name	Time	Method
Changes in plasma bone markers	Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment	Changes in baseline CTX, PNIP, Osteocalcin and alkaline phosphatase
Insulin secretion	Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment	By Oral glucose tolerance test
insulin sensitivity	Before and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatment	Derived from hyperglycemic clamp and HOMA-IR
Cardiorespiratory fitness	Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment	Changes in maximal oxygen uptake
Glucose homeostasis	Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment	Changes in HbA1c
Body composition	Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment	By DXA

Trial Locations

Locations (1)

Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen; 🇩🇰 Copenhagen, Denmark