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Completed

NCT Number: NCT02683135

Lifestyle Control of Postprandial Hyperglycemia

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-carbohydrate diet

Behavioral

Participants will engage in 4 days of high-carbohydrate low fat diet as recommended by the Canadian Diabetes Association. The macronutrients content will go as follow: 55% carbohydrate, 25% protein and 20% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.

Low-Carbohydrate Diet

Behavioral

Participants will engage in 4 days of low-carbohydrate high-fat diet. The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.

Low-carbohydrate diet with post-meal walking

Behavioral

Participants will follow the same diet as in the low-carbohydrate diet arm but also perform 15 minutes of walking beginning ~15 minutes after breakfast, lunch and dinner. Approximately 70 kcal (individualized) will be added to main meals to account for exercise energy expenditure. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.

Primary outcomes

  1. 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

  1. Change from baseline in circulating inflammatory cytokines after 4 days of intervention.

    Time frame: Fasting measurements taken on day 1 and day 5.

  2. Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.

    Time frame: Fasting measurements taken on day 1 and day 5.

  3. Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.

    Time frame: Fasting measurements taken on day 1 and day 5.

Other outcomes

  1. Change from baseline in flow-mediated dilation after single breakfast meal on day 1 of the intervention

    Time frame: Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm

  2. Change from baseline in plasma glucose after single breakfast meal on day 1 of the intervention

    Time frame: Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm

  3. Change from baseline in body weight after a single meal and 4 days of intervention.

    Time frame: Fasting measures on day 1 and day 5.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Medtronic

Registry information

Official study title

Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2016
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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