Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low-carbohydrate diet with post-meal walking
Intervention: Low-carbohydrate diet (Behavioral)
Low-carbohydrate diet with post-meal walking
Intervention: Low-carbohydrate diet with post-meal walking (Behavioral)
High-carbohydrate diet
Intervention: High-carbohydrate diet (Behavioral)
Low-carbohydrate diet
Intervention: Low-carbohydrate diet (Behavioral)
Outcomes
Primary Outcomes
Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.
Time Frame: 4-day average glucose levels assessed in each arm.
Secondary Outcomes
- Change from baseline in circulating inflammatory cytokines after 4 days of intervention.(Fasting measurements taken on day 1 and day 5.)
- Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.(Fasting measurements taken on day 1 and day 5.)
- Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.(Fasting measurements taken on day 1 and day 5.)
Investigators
Jonathan Little
Assistant Professor
University of British Columbia