Clinical trial NCT03207269: Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes
Official title: A High-protein Bedtime Snack to Control Morning Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting Plasma glucose
timeFrame: Day 4
Secondary outcomes:
measure: 24 h mean blood glucose
timeFrame: Average of three days during each intervention
measure: postprandial glucose
timeFrame: Average of three days during each intervention
measure: Fasting insulin
timeFrame: Average of three days during each intervention
measure: Fasting homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: Day 4
measure: Overnight blood glucose
timeFrame: Average of three days during each intervention
measure: Fasting continuous glucose monitoring glucose
timeFrame: Average of the three days during each intervention
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan.
state: British Columbia
Study officials:
References:
citation: Abbie E, Francois ME, Chang CR, Barry JC, Little JP. A low-carbohydrate protein-rich bedtime snack to control fasting and nocturnal glucose in type 2 diabetes: A randomized trial. Clin Nutr. 2020 Dec;39(12):3601-3606. doi: 10.1016/j.clnu.2020.03.008. Epub 2020 Mar 13.