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Completed

NCT Number: NCT03207269

Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

Approximately 3 million Canadians have type 2 diabetes, a condition where the blood sugar levels are too high, uncontrolled blood sugars lead to cardiovascular disease and other complications. Patients with type 2 diabetes are often advised to consume a snack before bed in order to help control morning blood sugar levels. However, scientific evidence for this dietary approach is limited and there is no data to help elucidate what the ideal bedtime snack is. We hypothesize that a high protein, high fat snack with very little carbohydrate, will be an effective bedtime snack for lowering morning glucose without spiking glucose levels in the night. In this study we will determine if a bedtime snack that is high in protein and fat but low in carbohydrate can help improve morning glucose control in people with type 2 diabetes. This information will provide scientific evidence for the potential health benefits of strategically-timed high protein, high fat snack consumption in people with type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

About this study

Fifteen patients with physician diagnosed type 2 diabetes (HbA1c 6.5-9%), between the ages of 30-80 years, and not on exogenous insulin therapy, will complete three, 3-day intervention periods (proof-of-concept randomized trial). Participants will consume a standardized diet for three days with either i) two hard-boiled eggs, ii) fruit yogurt; or iii) control no-bedtime snack, thirty minutes prior to bedtime. Fasting blood samples will be obtained on Day 4 in the morning after following each 3-day dietary intervention. Blood glucose will be monitored continuously across the intervention period using continuous glucose monitoring (CGM). CGM allows for the moment-to-moment changes in blood glucose to be examined for several days, allowing the unique opportunity to examine the glucose responses at different points of the day, including fasting hyperglycemia in the morning, nocturnal glucose, and postprandial glucose in response to meals. To our knowledge, CGM technology has never been used in a bedtime snacking study in type 2 diabetes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed Type 2 Diabetes
  • HbA1c between 6.5 - 9.0%
  • No dietary restraints (lactose intolerance, dislike eggs, celiac disease)

Exclusion criteria

  • Heart attack or stroke within last year
  • Exogenous insulin

Treatment and study plan

Dietary

Other

Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.

Primary outcomes

  1. Fasting Plasma glucose

    Time frame: Day 4

    Fasting Plasma glucose

Secondary outcomes

  1. 24 h mean blood glucose

    Time frame: Average of three days during each intervention

    continuous blood glucose monitoring

  2. postprandial glucose

    Time frame: Average of three days during each intervention

    breakfast AUC

  3. Fasting insulin

    Time frame: Average of three days during each intervention

    Fasting plasma insulin

  4. Fasting homeostasis model assessment of insulin resistance (HOMA-IR)

    Time frame: Day 4

    Calculated by fasting plasma glucose and insulin

  5. Overnight blood glucose

    Time frame: Average of three days during each intervention

    Glucose assessed during sleep by continuous glucose monitoring

  6. Fasting continuous glucose monitoring glucose

    Time frame: Average of the three days during each intervention

    15-minute average glucose assessed by CGM in the fasted state upon awakening

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

A High-protein Bedtime Snack to Control Morning Blood Glucose

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2017
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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