Clinical trial NCT02683135: Lifestyle Control of Postprandial Hyperglycemia
Official title: Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-02-17
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Large spikes in blood glucose experienced after meals in people with type 2 diabetes are known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve blood glucose control in people with type 2 diabetes but it is unclear how these two strategies interact to affect blood vessel function and inflammation. We will examine how following a short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts markers of blood vessel function and inflammation. We will also examine how a single low carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control and blood vessel function. Findings will help determine the best lifestyle approach for improving cardiovascular health in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes (at least 6 months ago)
* Aged 40-75
* Engaging in 2 or less moderate-to-vigorous exercise bouts per week in the last 3 months
* Ability to understand and communicate in English to interact with the personal trainer

Exclusion Criteria:

* Diagnosed coronary artery disease
* Any contraindications to exercise (e.g., musculoskeletal injury)
* Prior history of cardio- or cerebrovascular disease or myocardial infarction
* Hypertension that is not controlled by medication (systolic blood pressure (BP) \>160 mmHg and/or diastolic BP \>99 mmHg)
* Change in diabetes medications in the previous 6 months
* Diagnosed with peripheral neuropathy
* Taking exogenous insulin

Primary outcomes:
measure: Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.
timeFrame: 4-day average glucose levels assessed in each arm.
Secondary outcomes:
measure: Change from baseline in circulating inflammatory cytokines after 4 days of intervention.
timeFrame: Fasting measurements taken on day 1 and day 5.
measure: Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.
timeFrame: Fasting measurements taken on day 1 and day 5.
measure: Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.
timeFrame: Fasting measurements taken on day 1 and day 5.
Other outcomes:
measure: Change from baseline in flow-mediated dilation after single breakfast meal on day 1 of the intervention
timeFrame: Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
measure: Change from baseline in plasma glucose after single breakfast meal on day 1 of the intervention
timeFrame: Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
measure: Change from baseline in body weight after a single meal and 4 days of intervention.
timeFrame: Fasting measures on day 1 and day 5.
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: