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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide treatment | Experimental | 3 months of therapeutic semaglutide treatment |
|
| Semaglutide and Endurance exercise | Experimental | 12 weeks of endurance exercise concomitant to semaglutide treatment |
|
| Endurance exercise | Experimental | 12 weeks of endurance exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurance exercise training | Behavioral | Ergometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur Ingersen, MD | Contact | +45 60172697 | hansai@sund.ku.dk |
| Name | Affiliation | Role |
|---|---|---|
| Flemming Dela | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen | Recruiting | Copenhagen | 2200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37265222 | Derived | Ingersen A, Schmucker M, Alexandersen C, Graungaard B, Thorngreen T, Borch J, Holst JJ, Helge JW, Dela F. Effects of Aerobic Training and Semaglutide Treatment on Pancreatic beta-Cell Secretory Function in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2023 Oct 18;108(11):2798-2811. doi: 10.1210/clinem/dgad326. |
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Can be provided upon reasonable request
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Semaglutide | Drug | 3 months of therapeutic treatment with semaglutide |
|
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 |
| D004700 | Endocrine System Diseases |