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Lifestyle Control of Postprandial Hyperglycemia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02683135
Enrollment
16
Registered
2016-02-17
Start date
2015-11-30
Completion date
2017-06-01
Last updated
2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

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.

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.

BEHAVIORALLow-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.

Sponsors

Medtronic
CollaboratorINDUSTRY
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

MeasureTime frame
Change from baseline in plasma glucose after single breakfast meal on day 1 of the interventionBaseline 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.
Change from baseline in flow-mediated dilation after single breakfast meal on day 1 of the interventionBaseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026