Lifestyle Control of Postprandial Hyperglycemia

NCT02683135 | Completed

• 1 other identifier: H1501952
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

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.

  4-day average glucose levels assessed in each arm.

Secondary Outcomes (3)

• 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.

Other Outcomes (3)

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

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

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

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

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

  Fasting measures on day 1 and day 5.

Study Arms (3)

High-carbohydrate diet

ACTIVE COMPARATOR

Behavioral: High-carbohydrate diet

Low-carbohydrate diet

EXPERIMENTAL

Behavioral: Low-carbohydrate diet

Low-carbohydrate diet with post-meal walking

EXPERIMENTAL

Behavioral: Low-carbohydrate diet; Behavioral: Low-carbohydrate diet with post-meal walking

Interventions

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.

High-carbohydrate diet

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; Low-carbohydrate diet with post-meal walking

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.

Low-carbohydrate diet with post-meal walking

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Medtronic: collaborator

Study Sites (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, High-Protein Low-Carbohydrate; Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet, High-Protein; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jonathan P Little, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 17, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)