Type 2 Diabetes MellitusResolutionNCT02065544
Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise
A study testing behavioral weight loss and exercise in people with Type 2 Diabetes Mellitus, run by University of Vermont.
Trial summary
This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- behavioral weight loss and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- new diagnosis of type 2 diabetes since 12 months
- BMI>27
- HBA1c > 6.5, , 8.0
Who cannot join
- HBA1c >8.0
- BMI< 27
About this study
This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put >50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of < 6.5%.
Read the detailed description
This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put >50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of < 6.5%.
The study replicates the clinical situation where selected patients with new type 2 diabetes, who are motivated to try an intensive lifestyle intervention, might replicate our study intervention if we are able to show a high remission rate (e.g. > 50%) for individuals in the study.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- behavioral weight loss and exercise
- Keywords
- Type 2 diabetes mellitus, behavioral weight loss, exercise training, hemoglobin A1c
- 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.
behavioral weight loss and exerciseBehavioural
Weight loss and exercise counseling
| Study group | Role | What they receive |
|---|---|---|
| behavioral weight loss and exercise | Experimental | weight loss and exercise lifestyle intervention over a 6 month period Receives: Behavioral: behavioral weight loss and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.
Measured: 6-months
Secondary outcomes (3)
lipid profile
A lipid profile will be drawn before, and after the 6 month intervention
Measured: 6 months
HS-C Reactive Protein
A HS-C Reactive Protein will be drawn before and after the 6 month intervention.
Measured: 6 months
Aerobic Fitness
Aerobic fitness will be measured as Peak Vo2 on the treadmill before and after the 6 month intervention
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 posted19 Feb 2014 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Ades, University of Vermont
- Investigators
- Philip A Ades, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065544
- Sponsor's protocol ID
- CHRMS: M11-198
- Acronym
- Resolution
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise
- ClinicalTrials.gov ID
- NCT02065544
- Acronym / sponsor ID
- Resolution / CHRMS: M11-198
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, behavioral weight loss, exercise training, hemoglobin A1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Feb 2014 (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.
This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put >50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of < 6.5%.
Detailed description
This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put >50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of < 6.5%.
The study replicates the clinical situation where selected patients with new type 2 diabetes, who are motivated to try an intensive lifestyle intervention, might replicate our study intervention if we are able to show a high remission rate (e.g. > 50%) for individuals in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| behavioral weight loss and exercise | Experimental | Behavioral: behavioral weight loss and exerciseweight loss and exercise lifestyle intervention over a 6 month period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- new diagnosis of type 2 diabetes since 12 months
- BMI>27
- HBA1c > 6.5, , 8.0
Key exclusion criteria (2 listed)
- HBA1c >8.0
- BMI< 27
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 |
|---|---|---|
| behavioral weight loss and exerciseWeight loss and exercise counseling | Behavioural | behavioral weight loss and exercise |
Primary outcome
Hemoglobin A1c
Time frame: 6-months
HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.
3 secondary outcomes
lipid profile
Time frame: 6 months
HS-C Reactive Protein
Time frame: 6 months
Aerobic Fitness
Time frame: 6 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 19 Feb 2014.
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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.
Philip A Ades, MD principal investigator
University of Vermont
Questions about this trial
What is this clinical trial studying?
A study testing behavioral weight loss and exercise in people with Type 2 Diabetes Mellitus, run by University of Vermont.
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 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: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Hemoglobin A1c (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 19 Feb 2014.