Type 2 Diabetes Mellitus
Conditions
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.
Interventions
OTHERDietary
Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Plasma glucose | Day 4 | Fasting Plasma glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postprandial glucose | Average of three days during each intervention | breakfast AUC |
| Fasting insulin | Average of three days during each intervention | Fasting plasma insulin |
| 24 h mean blood glucose | Average of three days during each intervention | continuous blood glucose monitoring |
| Overnight blood glucose | Average of three days during each intervention | Glucose assessed during sleep by continuous glucose monitoring |
| Fasting continuous glucose monitoring glucose | Average of the three days during each intervention | 15-minute average glucose assessed by CGM in the fasted state upon awakening |
| Fasting homeostasis model assessment of insulin resistance (HOMA-IR) | Day 4 | Calculated by fasting plasma glucose and insulin |
Countries
Canada
Outcome results
None listed