Lifestyle Control of Postprandial Hyperglycemia

NCT ID: NCT02683135

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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High-carbohydrate diet

Group Type ACTIVE_COMPARATOR

High-carbohydrate diet

Intervention Type 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

Group Type EXPERIMENTAL

Low-carbohydrate diet

Intervention Type 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

Group Type EXPERIMENTAL

Low-carbohydrate diet

Intervention Type 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

Intervention Type 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.

Interventions

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High-carbohydrate diet

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.

Intervention Type BEHAVIORAL

Low-carbohydrate diet

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.

Intervention Type BEHAVIORAL

Low-carbohydrate diet with post-meal walking

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Little

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan P Little, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia, Okanagan.

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H1501952

Identifier Type: -

Identifier Source: org_study_id

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