An interventional study of Lifestyle Counselling in Type 2 Diabetes Mellitus, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 10 Years to 20 Years. Per ClinicalTrials.gov, last updated 2014-07-29.
Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 15 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Manitoba is the lead sponsor of 554 studies on the registry; 88 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting
Behavioral: Lifestyle Counselling
Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention
Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices
Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
Time frame: 16 weeks
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 16 weeks
The record gives a start of Sep 2012, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.