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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Endurance exercise training
Semaglutide
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Insulin secretion, Beta cell function

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Semaglutide treatment

Semaglutide and Endurance exercise

Endurance exercise

Arm Description

3 months of therapeutic semaglutide treatment

12 weeks of endurance exercise concomitant to semaglutide treatment

12 weeks of endurance exercise

Outcomes

Primary Outcome Measures

Insulin secretion
By hyperglycemic clamp
Insulin secretion
By hyperglycemic clamp
Insulin secretion
By hyperglycemic clamp

Secondary Outcome Measures

Insulin secretion
By Oral glucose tolerance test
insulin sensitivity
Derived from hyperglycemic clamp and HOMA-IR
Changes in plasma bone markers
Changes in baseline CTX, PNIP, Osteocalcin and alkaline phosphatase
Glucose homeostasis
Changes in HbA1c
Cardiorespiratory fitness
Changes in maximal oxygen uptake
Body composition
By DXA

Full Information

First Posted
May 4, 2020
Last Updated
February 8, 2021
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04383197
Brief Title
Exercise and GLP-1 RA on Insulin Secretion
Acronym
EXISECRET
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Insulin secretion, Beta cell function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide treatment
Arm Type
Experimental
Arm Description
3 months of therapeutic semaglutide treatment
Arm Title
Semaglutide and Endurance exercise
Arm Type
Experimental
Arm Description
12 weeks of endurance exercise concomitant to semaglutide treatment
Arm Title
Endurance exercise
Arm Type
Experimental
Arm Description
12 weeks of endurance exercise
Intervention Type
Behavioral
Intervention Name(s)
Endurance exercise training
Intervention Description
Ergometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
3 months of therapeutic treatment with semaglutide
Primary Outcome Measure Information:
Title
Insulin secretion
Description
By hyperglycemic clamp
Time Frame
Change from baseline insulin secretion after Exercise intervention(12 weeks).
Title
Insulin secretion
Description
By hyperglycemic clamp
Time Frame
Change from baseline insulin secretion after 3 months of therapeutic semaglutide treatment
Title
Insulin secretion
Description
By hyperglycemic clamp
Time Frame
Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment
Secondary Outcome Measure Information:
Title
Insulin secretion
Description
By Oral glucose tolerance test
Time Frame
Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Title
insulin sensitivity
Description
Derived from hyperglycemic clamp and HOMA-IR
Time Frame
Before and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Title
Changes in plasma bone markers
Description
Changes in baseline CTX, PNIP, Osteocalcin and alkaline phosphatase
Time Frame
Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Title
Glucose homeostasis
Description
Changes in HbA1c
Time Frame
Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Title
Cardiorespiratory fitness
Description
Changes in maximal oxygen uptake
Time Frame
Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Title
Body composition
Description
By DXA
Time Frame
Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Ingersen, MD
Phone
+45 60172697
Email
hansai@sund.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flemming Dela
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Ingersen, MD
Phone
+45 60 17 26 97
Email
hansai@sund.ku.dk
First Name & Middle Initial & Last Name & Degree
Flemming Dela, MD, DMsci
First Name & Middle Initial & Last Name & Degree
Arthur Ingersen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Can be provided upon reasonable request

Learn more about this trial

Exercise and GLP-1 RA on Insulin Secretion

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