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Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

Not Applicable
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Other: Dietary
Registration Number
NCT03207269
Lead Sponsor
University of British Columbia
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Diagnosed Type 2 Diabetes
  • HbA1c between 6.5 - 9.0%
  • No dietary restraints (lactose intolerance, dislike eggs, celiac disease)
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Exclusion Criteria
  • Heart attack or stroke within last year
  • Exogenous insulin
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
High protein no carbohydrateDietaryDietary. Two eggs will be consumed 30 minutes prior to bedtime. Energy content of dinner will be reduced to account for the calories in the bedtime snack.
High protein carbohydrate containingDietaryDietary. A low-fat yogurt will be consumed 30 minutes prior to bedtime. Protein will be matched to the high protein bedtime snack condition. Energy content of dinner will be reduced to account for the calories in the bedtime snack.
Primary Outcome Measures
NameTimeMethod
Fasting Plasma glucoseDay 4

Fasting Plasma glucose

Secondary Outcome Measures
NameTimeMethod
Fasting insulinAverage of three days during each intervention

Fasting plasma insulin

Fasting continuous glucose monitoring glucoseAverage of the three days during each intervention

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

postprandial glucoseAverage of three days during each intervention

breakfast AUC

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

Calculated by fasting plasma glucose and insulin

Overnight blood glucoseAverage of three days during each intervention

Glucose assessed during sleep by continuous glucose monitoring

24 h mean blood glucoseAverage of three days during each intervention

continuous blood glucose monitoring

Trial Locations

Locations (1)

University of British Columbia, Okanagan.

🇨🇦

Kelowna, British Columbia, Canada

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