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Lifestyle Control of Postprandial Hyperglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683135
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: High-carbohydrate diet Behavioral: Low-carbohydrate diet Behavioral: Low-carbohydrate diet with post-meal walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.
Study Start Date : November 2015
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High-carbohydrate diet Behavioral: 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.

Experimental: Low-carbohydrate diet 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.

Experimental: Low-carbohydrate diet with post-meal walking 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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683135


Locations
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Canada, British Columbia
University of British Columbia, Okanagan.
Kelowna, British Columbia, Canada, V1V 1V7
Sponsors and Collaborators
University of British Columbia
Medtronic
Investigators
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Principal Investigator: Jonathan P Little, PhD University of British Columbia
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Responsible Party: Jonathan Little, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02683135    
Other Study ID Numbers: H1501952
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases