Lifestyle Control of Postprandial Hyperglycemia

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683135
• Other study ID #: H1501952
• Status: Completed
• Phase: N/A
• First received: February 11, 2016
• Last updated: August 1, 2017
• Start date: November 2015
• Est. completion date: June 1, 2017

Study information

• Verified date: August 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	University of British Columbia, Okanagan.	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change from baseline in body weight after a single meal and 4 days of intervention.		Fasting measures on day 1 and day 5.
Primary	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	Change from baseline in circulating inflammatory cytokines after 4 days of intervention.		Fasting measurements taken on day 1 and day 5.
Secondary	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.
Secondary	Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.		Fasting measurements taken on day 1 and day 5.