Type 2 Diabetes MellitusBDTNCT01597154
Lifestyle Therapy for Youth With Type 2 Diabetes
A study testing Lifestyle Counselling in people with Type 2 Diabetes Mellitus, run by University of Manitoba at 1 site in Canada.
Trial summary
Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased physical activity and dietary changes) for the management of glycemia and cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM). Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Lifestyle Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to May 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- youth with a BMI considered overweight according to the International Obesity Task Force
- diagnosed with type 2 diabetes, confirmed with a 2-hour oral glucose tolerance test within two years of enrollment
Who cannot join
- youth with type 1 diabetes
- use of insulin or other anti-diabetic drugs
- youth with medication-induced diabetes
- youth who have recently been admitted to hospital with ketoacidosis
- youth have experienced weight loss or enrolled in a weightloss program in the last 6 months
- youth with an orthapaedic injury preventing them from exercising
- youth who have a history of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes
Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased physical activity and dietary changes) for the management of glycemia and cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).
Our hypothesis is that education regarding healthy lifestyle changes will significantly reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL cholesterol, serum triglycerides and apolipoprotein B.
Read the detailed description
Youth between the ages of 10-20 years living with type 2 diabetes and not currently on insulin therapy will be randomly assigned to either a lifestyle intervention group or a control group. The lifestyle intervention group will meet 2-3 times per week for 16 weeks to take part in healthy living education sessions involving physical activity, healthy cooking, healthy gardening and how to start and sustain a healthy lifestyle change. At the beginning and end of the 16 weeks the investigators will measure the participants' blood sugars, height, weight, cholesterol, triglycerides and liver enzymes. The investigators will also take a picture of their kidney, heart and blood vessels using ultrasound. Those youth assigned to the control group will receive the 16 week intervention following their 16 week control period.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Lifestyle Counselling
- Keywords
- Adolescent, Type 2 Diabetes, Peer mentorship
- 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.
Lifestyle CounsellingBehavioural
Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counselling | Experimental | Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting Receives: Behavioral: Lifestyle Counselling |
| Control | No intervention | Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
Measured: 16 weeks
Secondary outcomes (5)
Cardiometabolic risk Z score
This is a composite score based on BMI z-score, waist circumference, c-reactive protein (CRP), fibrinogen, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triglycerides (TG) and apolipoprotein B (apoB), and a marker of fatty liver disease, alanine transaminase (ALT)
Measured: 16 weeks
Presence of microalbuminuria
defined as a first morning albumin:creatinine ratio (ACR) 2.5-25 mg/mmol in a first morning urine collection
Measured: 16 weeks
Hypertension
defined as a systolic blood pressure load >25% or a mean 24 hour systolic blood pressure >95th %ile for sex and height on 24 hour ambulatory blood pressure monitoring
Measured: 16 weeks
Anthropometrics
Waist circumference in centimeters, body mass index (BMI) z-score and percent body fat will be assessed to determine if changes in body composition are associated with improvements in cardiometabolic risk
Measured: 16 weeks
Cardiovascular structure and function
Vascular health will be assessed with non-invasive assessments of arterial stiffness, endothelium-dependant relaxation and carotid intima media thickness which will be treated as continuous variables. Left ventricular structure and function will be assessed using standard M-mode and doppler ultrasound techniques
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 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.
- More trials run by University of ManitobaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Institute of Child Health
- Responsible party
- Principal investigator, Jon McGavock, University of Manitoba
- Investigators
- Jonathon McGavock, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597154
- Sponsor's protocol ID
- B2012:023
- Acronym
- BDT
- Status last verified
- Jul 2014
- First submitted
- 9 May 2012
- Last updated
- 29 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01597154
- Acronym / sponsor ID
- BDT / B2012:023
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Adolescent, Type 2 Diabetes, Peer mentorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Institute of Child Health
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 May 2012 (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.
Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased physical activity and dietary changes) for the management of glycemia and cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).
Our hypothesis is that education regarding healthy lifestyle changes will significantly reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL cholesterol, serum triglycerides and apolipoprotein B.
Detailed description
Youth between the ages of 10-20 years living with type 2 diabetes and not currently on insulin therapy will be randomly assigned to either a lifestyle intervention group or a control group. The lifestyle intervention group will meet 2-3 times per week for 16 weeks to take part in healthy living education sessions involving physical activity, healthy cooking, healthy gardening and how to start and sustain a healthy lifestyle change. At the beginning and end of the 16 weeks the investigators will measure the participants' blood sugars, height, weight, cholesterol, triglycerides and liver enzymes. The investigators will also take a picture of their kidney, heart and blood vessels using ultrasound. Those youth assigned to the control group will receive the 16 week intervention following their 16 week control period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counselling | Experimental | Behavioral: Lifestyle CounsellingExercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting |
| Control | No intervention | –Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- youth with a BMI considered overweight according to the International Obesity Task Force
- diagnosed with type 2 diabetes, confirmed with a 2-hour oral glucose tolerance test within two years of enrollment
Key exclusion criteria (7 listed)
- youth with type 1 diabetes
- use of insulin or other anti-diabetic drugs
- youth with medication-induced diabetes
- youth who have recently been admitted to hospital with ketoacidosis
- youth have experienced weight loss or enrolled in a weightloss program in the last 6 months
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 |
|---|---|---|
| Lifestyle CounsellingParticipants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices | Behavioural | Lifestyle counselling |
Primary outcome
Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
Time frame: 16 weeks
5 secondary outcomes
Cardiometabolic risk Z score
Time frame: 16 weeks
Presence of microalbuminuria
Time frame: 16 weeks
Hypertension
Time frame: 16 weeks
Anthropometrics
Time frame: 16 weeks
Cardiovascular structure and function
Time frame: 16 weeks
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 29 Jul 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.
Jonathon McGavock, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Counselling in people with Type 2 Diabetes Mellitus, run by University of Manitoba 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 2 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: finished, as of the sponsor's last update on 29 Jul 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 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. 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 determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay (time frame: 16 weeks). 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 29 Jul 2014.