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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04383197
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Flemming Dela, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Endurance exercise training Drug: Semaglutide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

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
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

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




Primary Outcome Measures :
  1. Insulin secretion [ Time Frame: Change from baseline insulin secretion after Exercise intervention(12 weeks). ]
    By hyperglycemic clamp

  2. Insulin secretion [ Time Frame: Change from baseline insulin secretion after 3 months of therapeutic semaglutide treatment ]
    By hyperglycemic clamp

  3. Insulin secretion [ Time Frame: Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment ]
    By hyperglycemic clamp


Secondary Outcome Measures :
  1. Insulin secretion [ Time Frame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment ]
    By Oral glucose tolerance test

  2. insulin sensitivity [ Time Frame: Before and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatment ]
    Derived from hyperglycemic clamp and HOMA-IR

  3. Changes in plasma bone markers [ Time Frame: Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment ]
    Changes in baseline CTX, PNIP, Osteocalcin and alkaline phosphatase

  4. Glucose homeostasis [ Time Frame: Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment ]
    Changes in HbA1c

  5. Cardiorespiratory fitness [ Time Frame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment ]
    Changes in maximal oxygen uptake

  6. Body composition [ Time Frame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment ]
    By DXA



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04383197


Contacts
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Contact: Arthur Ingersen, MD +45 60172697 hansai@sund.ku.dk

Locations
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Denmark
Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen Recruiting
Copenhagen, Denmark, 2200
Contact: Arthur Ingersen, MD    +45 60 17 26 97    hansai@sund.ku.dk   
Principal Investigator: Flemming Dela, MD, DMsci         
Sub-Investigator: Arthur Ingersen, MD         
Sponsors and Collaborators
University of Copenhagen

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Responsible Party: Flemming Dela, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04383197    
Other Study ID Numbers: H-19008233
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: yet to be decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flemming Dela, University of Copenhagen:
Insulin secretion
Beta cell function
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases