Clinical trial NCT04383197: Exercise and GLP-1 RA on Insulin Secretion
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Insulin secretion
Beta cell function
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insulin secretion
timeFrame: Change from baseline insulin secretion after Exercise intervention(12 weeks).
measure: Insulin secretion
timeFrame: Change from baseline insulin secretion after 3 months of therapeutic semaglutide treatment
measure: Insulin secretion
timeFrame: Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment
Secondary outcomes:
measure: Insulin secretion
timeFrame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
measure: insulin sensitivity
timeFrame: Before and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatment
measure: Changes in plasma bone markers
timeFrame: Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
measure: Glucose homeostasis
timeFrame: Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
measure: Cardiorespiratory fitness
timeFrame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
measure: Body composition
timeFrame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Flemming Dela
role: PRINCIPAL_INVESTIGATOR
References: