Type 2 DiabetesEXISECRETNCT04383197
Exercise and GLP-1 RA on Insulin Secretion
A study testing Endurance exercise training and Semaglutide in people with Type 2 Diabetes, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Endurance exercise training and Semaglutide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Dec 2019to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes
- BMI 28-35
- Moderately preserved insulin secretory capacity (determined by glucagon test)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen
Copenhagen, 2200
Arthur Ingersen, MD, +45 60 17 26 97, hansai@sund.ku.dk
Flemming Dela, MD, DMsci
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Endurance exercise training, Semaglutide
- Keywords
- Insulin secretion, Beta cell function
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance exercise trainingBehavioural
Ergometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week
SemaglutideDrug
3 months of therapeutic treatment with semaglutide
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide treatment | Experimental | 3 months of therapeutic semaglutide treatment Receives: Drug: Semaglutide |
| Semaglutide and Endurance exercise | Experimental | 12 weeks of endurance exercise concomitant to semaglutide treatment Receives: Behavioral: Endurance exercise training; Drug: Semaglutide |
| Endurance exercise | Experimental | 12 weeks of endurance exercise Receives: Behavioral: Endurance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin secretion
By hyperglycemic clamp
Measured: Change from baseline insulin secretion after Exercise intervention(12 weeks).
Insulin secretion
By hyperglycemic clamp
Measured: Change from baseline insulin secretion after 3 months of therapeutic semaglutide treatment
Insulin secretion
By hyperglycemic clamp
Measured: Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment
Secondary outcomes (6)
Insulin secretion
By Oral glucose tolerance test
Measured: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
insulin sensitivity
Derived from hyperglycemic clamp and HOMA-IR
Measured: 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
Measured: Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Glucose homeostasis
Changes in HbA1c
Measured: 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
Measured: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Body composition
By DXA
Measured: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start10 Dec 2019
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flemming Dela, University of Copenhagen
- Investigators
- Flemming Dela, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383197
- Sponsor's protocol ID
- H-19008233
- Acronym
- EXISECRET
- Status last verified
- Feb 2021
- First submitted
- 4 May 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Can be provided upon reasonable request
Publications
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.
PubMed 37265222
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04383197
- Acronym / sponsor ID
- EXISECRET / H-19008233
- Conditions
- Type 2 Diabetes
- Keywords
- Insulin secretion, Beta cell function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semaglutide treatment | Experimental | Drug: Semaglutide3 months of therapeutic semaglutide treatment |
| Semaglutide and Endurance exercise | Experimental | Behavioral: Endurance exercise training, Drug: Semaglutide12 weeks of endurance exercise concomitant to semaglutide treatment |
| Endurance exercise | Experimental | Behavioral: Endurance exercise training12 weeks of endurance exercise |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes
- BMI 28-35
- Moderately preserved insulin secretory capacity (determined by glucagon test)
Key exclusion criteria (7 listed)
- Insulin treatment
- Hypertension grade 3
- Heart disease
- Medical history with pancreatitis
- Diagnosed with neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance exercise trainingErgometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week | Behavioural | Endurance exercise, Semaglutide and Endurance exercise |
| Semaglutide3 months of therapeutic treatment with semaglutide | Drug | Semaglutide and Endurance exercise, Semaglutide treatment |
Primary outcome
Insulin secretion
Time frame: Change from baseline insulin secretion after Exercise intervention(12 weeks).
By hyperglycemic clamp
Insulin secretion
Time frame: Change from baseline insulin secretion after 3 months of therapeutic semaglutide treatment
By hyperglycemic clamp
Insulin secretion
Time frame: Change from baseline insulin secretion after 3 months of combined exercise and therapeutic semaglutide treatment
By hyperglycemic clamp
6 secondary outcomes
Insulin secretion
Time frame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
insulin sensitivity
Time frame: Before and after (2 days) Exercise intervention(12 weeks). Before and after 3 months of therapeutic semaglutide treatment
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
Glucose homeostasis
Time frame: Before and after (2 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Cardiorespiratory fitness
Time frame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Body composition
Time frame: Before and after (3 days) Exercise intervention (12 weeks). Before and after 3 months of therapeutic semaglutide treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 37265222Ingersen 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.
- Individual participant dataSharing planned: No. Can be provided upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flemming Dela principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance exercise training and Semaglutide in people with Type 2 Diabetes, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur Ingersen, MD (+45 60172697, hansai@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin secretion (time frame: Change from baseline insulin secretion after Exercise intervention(12 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.