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

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University of Copenhagen

Status

Unknown

Conditions

Type 2 Diabetes

Treatments

Drug: Semaglutide
Behavioral: Endurance exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT04383197
H-19008233

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups

Semaglutide treatment
Experimental group
Description:
3 months of therapeutic semaglutide treatment
Treatment:
Drug: Semaglutide
Semaglutide and Endurance exercise
Experimental group
Description:
12 weeks of endurance exercise concomitant to semaglutide treatment
Treatment:
Behavioral: Endurance exercise training
Drug: Semaglutide
Endurance exercise
Experimental group
Description:
12 weeks of endurance exercise
Treatment:
Behavioral: Endurance exercise training

Trial contacts and locations

1

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Central trial contact

Arthur Ingersen, MD

Data sourced from clinicaltrials.gov

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