Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251301
• Other study ID #: H14-01636
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: May 1, 2017
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Skim Milk
250 ml skim milk will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.

Behavioral:
• High intensity interval training
All participants will undergo a 12 week high intensity interval training program consisting of 3 supervised sessions a week of 4-10 x 1 min high intensity interval alternating with 1 min of recovery.

Other:
• Placebo
250 mL water will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.

Dietary Supplement:
• Macronutrient isoenergetic control
250 mL of protein+cho matched drink will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.

Locations

Country	Name	City	State
Canada	University of British Columbia, Okanagan.	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Dairy Farmers of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in fasting plasma non esterified free fatty acid concentration at end of week 12 of intervention.		Baseline, Week 12
Other	Change from baseline in systolic blood pressure at end of week 12 of intervention.		Baseline, Week 12
Other	Change from baseline in diastolic blood pressure at end of week 12 of intervention.		Baseline, Week 12.
Other	Change from baseline in circulating inflammatory cytokines at end of week 12 of intervention.		Baseline, Week 12.
Other	Change from baseline in body composition as measured by dual absorbancy x ray at end of week 12 of intervention.		Baseline, Week 12.
Other	Change from baseline in task switching capabilities at end of week 12 of intervention.		Baseline, Week 12.
Primary	Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention		Baseline, Week 12.
Secondary	Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.		Baseline, Week 12.
Secondary	Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.		Baseline, Week 12.
Secondary	Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.		Baseline, Week 12.
Secondary	Change from baseline in flow mediated dilation of brachial artery at end of week 12 of intervention.		Baseline, Week 12.
Secondary	Change from baseline in peak oxygen uptake as a measure of aerobic fitness at end of week 12 of intervention.		Baseline, Week 12