Clinical trial NCT02251301: Milk Plus Exercise: A Novel Strategy to Treat Diabetes.
Official title: The Effect of Adding Milk in Proximity to Exercise During an Interval Training Intervention in Type 2 Diabetes (T2D) on Metabolic and Cardiovascular Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Dairy Farmers of Canada
First posted: 2014-09-29
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate whether combining interval training with skim milk supplementation will result in improved glucose control and markers of cardiovascular health in people with type 2 diabetes. Participants will complete supervised interval training three times a week over a 12 week training period while consuming skim-milk, whey/casein protein drink, or a placebo beverage that does not contain any calories or vitamins/minerals immediately and 1 hour after each training session. After twelve weeks participants will repeat baseline tests to examine any effects of the intervention on their glucose control, fitness, blood vessel function, body composition, and blood markers of inflammation.


Eligibility criteria: Inclusion Criteria:

* Aged between 40 and 75.
* Diagnosed with type 2 diabetes for more than 6 months.
* On stable medication for the last 6 months

Exclusion Criteria:

* Type 2 diabetes controlled with exogenous insulin
* Uncontrolled hypertension (blood pressure \>160/90 mmHg)
* History of heart disease, myocardial infarction or stroke
* Any other contraindications to exercise

Primary outcomes:
measure: Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention
timeFrame: Baseline, Week 12.
Secondary outcomes:
measure: Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.
timeFrame: Baseline, Week 12.
measure: Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.
timeFrame: Baseline, Week 12.
measure: Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.
timeFrame: Baseline, Week 12.
measure: Change from baseline in flow mediated dilation of brachial artery at end of week 12 of intervention.
timeFrame: Baseline, Week 12.
measure: Change from baseline in peak oxygen uptake as a measure of aerobic fitness at end of week 12 of intervention.
timeFrame: Baseline, Week 12
Other outcomes:
measure: Change from baseline in fasting plasma non esterified free fatty acid concentration at end of week 12 of intervention.
timeFrame: Baseline, Week 12
measure: Change from baseline in systolic blood pressure at end of week 12 of intervention.
timeFrame: Baseline, Week 12
measure: Change from baseline in diastolic blood pressure at end of week 12 of intervention.
timeFrame: Baseline, Week 12.
measure: Change from baseline in circulating inflammatory cytokines at end of week 12 of intervention.
timeFrame: Baseline, Week 12.
measure: Change from baseline in body composition as measured by dual absorbancy x ray at end of week 12 of intervention.
timeFrame: Baseline, Week 12.
measure: Change from baseline in task switching capabilities at end of week 12 of intervention.
timeFrame: Baseline, Week 12.
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan.
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jonathan P Little, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Francois ME, Pistawka KJ, Halperin FA, Little JP. Cardiovascular benefits of combined interval training and post-exercise nutrition in type 2 diabetes. J Diabetes Complications. 2018 Feb;32(2):226-233. doi: 10.1016/j.jdiacomp.2017.10.002. Epub 2017 Nov 29.