Diabetes MellitusEarly Phase 1DEALNCT00877864
Diabetes Exercise and Lifestyle Trial
A Early Phase 1 study testing High volume combined aerobic/resistance exercise, Low volume combined aerobic/resistance exercise and High volume combined A/R exercise, printouts, pedometers in people with Diabetes Mellitus, run by University of Calgary at 1 site in Canada.
Trial summary
The objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin). Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- High volume combined aerobic/resistance exercise, Low volume combined aerobic/resistance exercise and High volume combined A/R exercise, printouts, pedometers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Dec 2012
- Phase
- Early Phase 1
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- A1c 0.700-0.099
- ability to read and write English
- signed ICF
Who cannot join
- participation in previous 6 months in exercise > 2 times per week for at least 20 min per session
- insulin therapy changes in medication for diabetes, BP or Lipids
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin).
Read the detailed description
Background Rationale: Structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. It has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. The supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. A stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.
- Conditions
- Diabetes Mellitus
- Being tested
- High volume combined aerobic/resistance exercise, Low volume combined aerobic/resistance exercise, High volume combined A/R exercise, printouts, pedometers, Low volume combined A/R exercise, printouts, pedometers, Printed PA information, pedometers and step log group
- Keywords
- diabetes, exercise, printed materials
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High volume combined aerobic/resistance exerciseBehavioural
High volume combined aerobic/resistance exercise
Low volume combined aerobic/resistance exerciseBehavioural
Low volume combined aerobic/resistance exercise
High volume combined A/R exercise, printouts, pedometersBehavioural
High volume combined aerobic/resistance exercise, printouts, pedometers
Low volume combined A/R exercise, printouts, pedometersBehavioural
Low volume combined aerobic/resistance exercise, printouts, pedometers
Printed PA information, pedometers and step log groupBehavioural
Printed PA information, pedometers and step log group
ControlBehavioural
No exercise program provided by the study
| Study group | Role | What they receive |
|---|---|---|
| High volume combined aerobic/resistance exercise | Active comparator | Not described Receives: Behavioral: High volume combined aerobic/resistance exercise |
| Low volume combined aerobic/resistance exercise | Active comparator | Low volume combined aerobic/resistance exercise Receives: Behavioral: Low volume combined aerobic/resistance exercise |
| High volume combined A/R exercise, printouts, pedometers | Active comparator | High volume combined aerobic/resistance exercise, printouts, pedometers Receives: Behavioral: High volume combined A/R exercise, printouts, pedometers |
| Low volume combined A/R exercise, printouts, pedometers | Active comparator | Low volume combined aerobic/resistance exercise, printouts, pedometers Receives: Behavioral: Low volume combined A/R exercise, printouts, pedometers |
| Printed PA information, pedometers and step log group | Active comparator | Printed physical activity information, pedometers and step log group Receives: Behavioral: Printed PA information, pedometers and step log group |
| Control | Placebo comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be A1c at the end of 6 months supervised exercise period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Ron Sigal, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877864
- Sponsor's protocol ID
- DEAL- 22251
- Other IDs
- CHREB 22251
- Acronym
- DEAL
- Status last verified
- Aug 2011
- First submitted
- 6 Apr 2009
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Exercise and Lifestyle Trial
- ClinicalTrials.gov ID
- NCT00877864
- Acronym / sponsor ID
- DEAL / DEAL- 22251
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, exercise, printed materials
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Apr 2009 (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 objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin).
Detailed description
Background Rationale: Structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. It has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. The supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. A stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High volume combined aerobic/resistance exercise | Active comparator | Behavioral: High volume combined aerobic/resistance exercise |
| Low volume combined aerobic/resistance exercise | Active comparator | Behavioral: Low volume combined aerobic/resistance exerciseLow volume combined aerobic/resistance exercise |
| High volume combined A/R exercise, printouts, pedometers | Active comparator | Behavioral: High volume combined A/R exercise, printouts, pedometersHigh volume combined aerobic/resistance exercise, printouts, pedometers |
| Low volume combined A/R exercise, printouts, pedometers | Active comparator | Behavioral: Low volume combined A/R exercise, printouts, pedometersLow volume combined aerobic/resistance exercise, printouts, pedometers |
| Printed PA information, pedometers and step log group | Active comparator | Behavioral: Printed PA information, pedometers and step log groupPrinted physical activity information, pedometers and step log group |
| Control | Placebo comparator | Behavioral: Control |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes
- A1c 0.700-0.099
- ability to read and write English
- signed ICF
Key exclusion criteria (2 listed)
- participation in previous 6 months in exercise > 2 times per week for at least 20 min per session
- insulin therapy changes in medication for diabetes, BP or Lipids
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 |
|---|---|---|
| High volume combined aerobic/resistance exerciseHigh volume combined aerobic/resistance exercise | Behavioural | High volume combined aerobic/resistance exercise |
| Low volume combined aerobic/resistance exerciseLow volume combined aerobic/resistance exercise | Behavioural | Low volume combined aerobic/resistance exercise |
| High volume combined A/R exercise, printouts, pedometersHigh volume combined aerobic/resistance exercise, printouts, pedometers | Behavioural | High volume combined A/R exercise, printouts, pedometers |
| Low volume combined A/R exercise, printouts, pedometersLow volume combined aerobic/resistance exercise, printouts, pedometers | Behavioural | Low volume combined A/R exercise, printouts, pedometers |
| Printed PA information, pedometers and step log groupPrinted PA information, pedometers and step log group | Behavioural | Printed PA information, pedometers and step log group |
| ControlNo exercise program provided by the study | Behavioural | Control |
Primary outcome
The primary outcome will be A1c at the end of 6 months supervised exercise period.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
Related trials for Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
Ron Sigal, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing High volume combined aerobic/resistance exercise, Low volume combined aerobic/resistance exercise and High volume combined A/R exercise, printouts, pedometers in people with Diabetes Mellitus, run by University of Calgary at 1 site in Canada.
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 4 inclusion and 2 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 5 Aug 2011. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The primary outcome will be A1c at the end of 6 months supervised exercise period. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2011.