Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

University of British Columbia

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Dietary

Study type: Interventional

Funder types: Other

Identifiers

NCT03207269

H17-01055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

High protein no carbohydrate

Experimental group

Description:

Dietary. 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.

Treatment:

Other: Dietary

High protein carbohydrate containing

Active Comparator group

Description:

Dietary. 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.

Treatment:

Other: Dietary

Control no snack

No Intervention group

Description:

No snack will be consumed prior to bed.