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Lifestyle Control of Postprandial Hyperglycemia

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-carbohydrate diet
Low-carbohydrate diet
Low-carbohydrate diet with post-meal walking
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia, Okanagan.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

High-carbohydrate diet

Low-carbohydrate diet

Low-carbohydrate diet with post-meal walking

Arm Description

Outcomes

Primary Outcome Measures

Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.

Secondary Outcome Measures

Change from baseline in circulating inflammatory cytokines after 4 days of intervention.
Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.
Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.

Full Information

First Posted
February 11, 2016
Last Updated
August 1, 2017
Sponsor
University of British Columbia
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02683135
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-carbohydrate diet
Arm Type
Active Comparator
Arm Title
Low-carbohydrate diet
Arm Type
Experimental
Arm Title
Low-carbohydrate diet with post-meal walking
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
High-carbohydrate diet
Intervention Description
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
Intervention Name(s)
Low-carbohydrate diet
Intervention Description
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
Intervention Name(s)
Low-carbohydrate diet with post-meal walking
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change from baseline in circulating inflammatory cytokines after 4 days of intervention.
Time Frame
Fasting measurements taken on day 1 and day 5.
Title
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.
Title
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 Pre-specified Outcome Measures:
Title
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
Title
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
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Little, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia, Okanagan.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Lifestyle Control of Postprandial Hyperglycemia

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