Exercise and GLP-1 RA on Insulin Secretion

Type 2 Diabetes Clinical Trial

— EXISECRET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04383197
• Other study ID #: H-19008233
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: August 2022

Study information

• Verified date: February 2021
• Source: University of Copenhagen
• Contact: Arthur Ingersen, MD
• Phone: +45 60172697
• Email: hansai[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Endurance exercise training
Ergometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week

Drug:
• Semaglutide
3 months of therapeutic treatment with semaglutide

Locations

Country	Name	City	State
Denmark	Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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