Diabetes Mellitus Type 2Phase 4NCT01244971
Exercise and Acarbose in Type 2 Diabetes
A Phase 4 study testing Acarbose, Exercise and Exercise + Acarbose in people with Diabetes Mellitus Type 2, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Acarbose, Exercise and Exercise + Acarbose
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2004to Jun 2004
- Phase
- Phase 4
- 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 45 to 60 years
- All sexes
- Adult
Inclusion Criteria: Men and women, diagnosis of type 2 diabetes established since at least three months, treatment with diet or maximum one oral anti-diabetic drug, GHb < 8.5 %, age 45 - 60 years, BMI 25 - 30 kg/m2, no participation in any regular exercise program.
-
Exclusion Criteria: Unable to perform exercise, significant GI-disease, severe heart-disease, renal failure
-
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Enheten för Metabol Kontroll, Endokrinkliniken, Karolinska University Hospital
Stockholm, Stockholm County, 17176
About this study
Official title: Effect of Exercise Training - Alone or in Combination With Acarbose - on Clinical and Metabolic Factors, and Studies of Cellular and Moleculargenetic Factors, in Type 2 Diabetes.
The purpose of this study is to investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Our hypothesis is that the combination therapy will be superior to monotherapy with exercise or Acarbose.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Acarbose, Exercise, Exercise + Acarbose
- 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.
AcarboseDrug
100mg, 3 times daily
ExerciseBehavioural
Moderate combined exercise, 50 minutes 3 times per week
Exercise + AcarboseOther
See respective monotherapy description
| Study group | Role | What they receive |
|---|---|---|
| Acarbose | Active comparator | Not described Receives: Drug: Acarbose |
| Exercise | Active comparator | Not described Receives: Behavioral: Exercise |
| Exercise + Acarbose | Experimental | Not described Receives: Other: Exercise + Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Glycated A1c
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startJan 2004
- Primary completionJun 2004
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 Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Bayer
- Investigators
- Suad Efendic, Professor, Study chair, Dpt of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244971
- Sponsor's protocol ID
- DNR 03-539
- Status last verified
- Dec 2003
- First submitted
- 19 Nov 2010
- Last updated
- 22 Nov 2010
- Results posted
- No
Publications
Wagner H, Degerblad M, Thorell A, Nygren J, Stahle A, Kuhl J, Brismar TB, Ohrvik J, Efendic S, Bavenholm PN. Combined treatment with exercise training and acarbose improves metabolic control and cardiovascular risk factor profile in subjects with mild type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1471-7. doi: 10.2337/dc05-2513.
PubMed 16801564
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training - Alone or in Combination With Acarbose - on Clinical and Metabolic Factors, and Studies of Cellular and Moleculargenetic Factors, in Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT01244971
- Acronym / sponsor ID
- DNR 03-539
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Bayer
- Study start
- Jan 2004
- Primary completion
- Jun 2004 (actual)
- First posted
- 22 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 investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Our hypothesis is that the combination therapy will be superior to monotherapy with exercise or Acarbose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acarbose | Active comparator | Drug: Acarbose |
| Exercise | Active comparator | Behavioral: Exercise |
| Exercise + Acarbose | Experimental | Other: Exercise + Acarbose |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Age groups
- Adult
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 |
|---|---|---|
| Acarbose100mg, 3 times daily | Drug | Acarbose |
| ExerciseModerate combined exercise, 50 minutes 3 times per week | Behavioural | Exercise |
| Exercise + AcarboseSee respective monotherapy description | Other | Exercise + Acarbose |
Primary outcome
Glycemic control
Time frame: 12 weeks
Glycated A1c
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 22 Nov 2010.
- Results publication: PubMed 16801564Wagner H, Degerblad M, Thorell A, Nygren J, Stahle A, Kuhl J, Brismar TB, Ohrvik J, Efendic S, Bavenholm PN. Combined treatment with exercise training and acarbose improves metabolic control and cardiovascular risk factor profile in subjects with mild type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1471-7. doi: 10.2337/dc05-2513.
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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.
Suad Efendic, Professor study chair
Dpt of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acarbose, Exercise and Exercise + Acarbose in people with Diabetes Mellitus Type 2, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Nov 2010. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 12 weeks). 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 NCT01244971, 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 22 Nov 2010.