Diabetes Mellitus, Type 2NCT01234155
Exercise Training and Type 2 Diabetes
A study testing Exercise Training - Interval Walking and Exercise - Continuous Walking in people with Diabetes Mellitus, Type 2, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to assess whether 4-months of interval-walking exercise training improves glycemic control in individuals with type 2 diabetes mellitus. The effects of interval-walking training will be compared to continuous-walking exercise in a randomised, controlled trial design. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exercise Training - Interval Walking and Exercise - Continuous Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Nov 2014
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 to 80
- normal glucose tolerance, impaired glucose tolerance, or type 2 diabetes (as evidenced by use of oral hypoglycemic medication or 2-hour OGTT glucose > 11.1 mmol/l)
Who cannot join
- Insulin treatment or type 1 diabetes
- BMI <19 or >40
- Physically active
- Undergoing weight-loss/gain
- Pregnancy
- Contraindication to exercise (ECG/CPX)
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- Significant cardiovascular disease
- History of renal/hepatic/gastrointestinal/pulmonary disease
- Clotting or bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess whether 4-months of interval-walking exercise training improves glycemic control in individuals with type 2 diabetes mellitus. The effects of interval-walking training will be compared to continuous-walking exercise in a randomised, controlled trial design. Changes in glycemic control will be examined using oral glucose tolerance tests (OGTT) with stable isotope methodology. In addition, insulin sensitivity and secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exercise Training - Interval Walking, Exercise - Continuous Walking
- Keywords
- Exercise, Diabetes, Obesity, Insulin Sensitivity, Insulin Secretion, Beta-cell Function, Glycemic Control, GIP, GLP-1
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Diabetes Mellitus, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Training - Interval WalkingBehavioural
Duration: 4 months. Exercise training sessions will be performed 3-5 days/week. Sessions will consist of walking for 3 minutes at 70% VO2max followed by 3 minutes at 40% VO2max for up to 60 minutes/day.
Exercise - Continuous WalkingBehavioural
Duration: 4 months. Exercise training sessions will be performed 3-5 days/week and will consist of walking for up to 60 minutes/day at 55% VO2max.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Exercise - Continuous Walking | Experimental | Not described Receives: Behavioral: Exercise - Continuous Walking |
| Exercise - Interval Walking | Experimental | Not described Receives: Behavioral: Exercise Training - Interval Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured.
Measured: 0 and 4 months
Secondary outcomes (2)
Beta-cell Function
Glucose tolerance tests and hyperglycemic clamps combined with GLP-1 / GIP will be conducted. Glucose tracer kinetics and C-peptide deconvolution will be used to assess pancreatic function.
Measured: 0 and 4 months
Body Composition
DXA and MRI will be used to assess changes in whole body and regional adiposity.
Measured: 0 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2012
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Solomon, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Thomas P Solomon, Ph.D., Principal investigator, Copenhagen University Hospital, RigshospitaletKristian Karstoft, M.D., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234155
- Sponsor's protocol ID
- H-1-2010-027
- Status last verified
- Dec 2014
- First submitted
- 1 Nov 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Karstoft K, Winding K, Knudsen SH, James NG, Scheel MM, Olesen J, Holst JJ, Pedersen BK, Solomon TP. Mechanisms behind the superior effects of interval vs continuous training on glycaemic control in individuals with type 2 diabetes: a randomised controlled trial. Diabetologia. 2014 Oct;57(10):2081-93. doi: 10.1007/s00125-014-3334-5. Epub 2014 Aug 7.
PubMed 25099941Solomon TP, Malin SK, Karstoft K, Kashyap SR, Haus JM, Kirwan JP. Pancreatic beta-cell function is a stronger predictor of changes in glycemic control after an aerobic exercise intervention than insulin sensitivity. J Clin Endocrinol Metab. 2013 Oct;98(10):4176-86. doi: 10.1210/jc.2013-2232. Epub 2013 Aug 21.
PubMed 23966244Solomon TP, Malin SK, Karstoft K, Haus JM, Kirwan JP. The influence of hyperglycemia on the therapeutic effect of exercise on glycemic control in patients with type 2 diabetes mellitus. JAMA Intern Med. 2013 Oct 28;173(19):1834-6. doi: 10.1001/jamainternmed.2013.7783. No abstract available.
PubMed 23817567Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.
PubMed 23002086
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01234155
- Acronym / sponsor ID
- H-1-2010-027
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise, Diabetes, Obesity, Insulin Sensitivity, Insulin Secretion, Beta-cell Function, Glycemic Control, GIP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Nov 2010 (estimated)
- 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 assess whether 4-months of interval-walking exercise training improves glycemic control in individuals with type 2 diabetes mellitus. The effects of interval-walking training will be compared to continuous-walking exercise in a randomised, controlled trial design. Changes in glycemic control will be examined using oral glucose tolerance tests (OGTT) with stable isotope methodology. In addition, insulin sensitivity and secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Exercise - Continuous Walking | Experimental | Behavioral: Exercise - Continuous Walking |
| Exercise - Interval Walking | Experimental | Behavioral: Exercise Training - Interval Walking |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 to 80
- normal glucose tolerance, impaired glucose tolerance, or type 2 diabetes (as evidenced by use of oral hypoglycemic medication or 2-hour OGTT glucose > 11.1 mmol/l)
Key exclusion criteria (9 listed)
- Insulin treatment or type 1 diabetes
- BMI <19 or >40
- Physically active
- Undergoing weight-loss/gain
- Pregnancy
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 |
|---|---|---|
| Exercise Training - Interval WalkingDuration: 4 months. Exercise training sessions will be performed 3-5 days/week. Sessions will consist of walking for 3 minutes at 70% VO2max followed by 3 minutes at 40% VO2max for up to 60 minutes/day. | Behavioural | Exercise - Interval Walking |
| Exercise - Continuous WalkingDuration: 4 months. Exercise training sessions will be performed 3-5 days/week and will consist of walking for up to 60 minutes/day at 55% VO2max. | Behavioural | Exercise - Continuous Walking |
Primary outcome
Glycemic Control
Time frame: 0 and 4 months
Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured.
2 secondary outcomes
Beta-cell Function
Time frame: 0 and 4 months
Body Composition
Time frame: 0 and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 25099941Karstoft K, Winding K, Knudsen SH, James NG, Scheel MM, Olesen J, Holst JJ, Pedersen BK, Solomon TP. Mechanisms behind the superior effects of interval vs continuous training on glycaemic control in individuals with type 2 diabetes: a randomised controlled trial. Diabetologia. 2014 Oct;57(10):2081-93. doi: 10.1007/s00125-014-3334-5. Epub 2014 Aug 7.
- Derived from this study: PubMed 23966244Solomon TP, Malin SK, Karstoft K, Kashyap SR, Haus JM, Kirwan JP. Pancreatic beta-cell function is a stronger predictor of changes in glycemic control after an aerobic exercise intervention than insulin sensitivity. J Clin Endocrinol Metab. 2013 Oct;98(10):4176-86. doi: 10.1210/jc.2013-2232. Epub 2013 Aug 21.
- Derived from this study: PubMed 23817567Solomon TP, Malin SK, Karstoft K, Haus JM, Kirwan JP. The influence of hyperglycemia on the therapeutic effect of exercise on glycemic control in patients with type 2 diabetes mellitus. JAMA Intern Med. 2013 Oct 28;173(19):1834-6. doi: 10.1001/jamainternmed.2013.7783. No abstract available.
- Derived from this study: PubMed 23002086Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.
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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.
Thomas P Solomon, Ph.D. principal investigator
Copenhagen University Hospital, Rigshospitalet
Kristian Karstoft, M.D. principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training - Interval Walking and Exercise - Continuous Walking in people with Diabetes Mellitus, Type 2, run by Copenhagen University Hospital, Rigshospitalet 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 3 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (time frame: 0 and 4 months). 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 NCT01234155, which also lists 4 linked publications.
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 3 Dec 2014.