Exercise and GLP-1 RA on Insulin Secretion (EXISECRET)

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Semaglutide; Behavioral: Endurance exercise training

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arthur Ingersen, MD; Phone Number: +45 60172697; Email: hansai@sund.ku.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Recruiting
    • XLab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen
    • Contact: Arthur Ingersen, MD; Phone Number: +45 60 17 26 97; Email: hansai@sund.ku.dk
    • Principal Investigator: Flemming Dela, MD, DMsci
    • Sub-Investigator: Arthur Ingersen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Semaglutide treatment; 3 months of therapeutic semaglutide treatment	Drug: Semaglutide; 3 months of therapeutic treatment with semaglutide
EXPERIMENTAL: Semaglutide and Endurance exercise; 12 weeks of endurance exercise concomitant to semaglutide treatment	Drug: Semaglutide; 3 months of therapeutic treatment with semaglutide; Behavioral: Endurance exercise training; Ergometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week
EXPERIMENTAL: Endurance exercise; 12 weeks of endurance exercise	Behavioral: Endurance exercise training; Ergometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Glucose homeostasis	Changes in HbA1c	Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
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
Body composition	By DXA	Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Flemming Dela, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2019
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Beta cell function; Insulin secretion
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H-19008233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Can be provided upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No