Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A High-protein Bedtime Snack to Control Morning Blood Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207269
• Other study ID #: H17-01055
• Status: Completed
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Dietary
Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.

Locations

Country	Name	City	State
Canada	University of British Columbia, Okanagan.	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma glucose	Fasting Plasma glucose	Day 4
Secondary	24 h mean blood glucose	continuous blood glucose monitoring	Average of three days during each intervention
Secondary	postprandial glucose	breakfast AUC	Average of three days during each intervention
Secondary	Fasting insulin	Fasting plasma insulin	Average of three days during each intervention
Secondary	Fasting homeostasis model assessment of insulin resistance (HOMA-IR)	Calculated by fasting plasma glucose and insulin	Day 4
Secondary	Overnight blood glucose	Glucose assessed during sleep by continuous glucose monitoring	Average of three days during each intervention
Secondary	Fasting continuous glucose monitoring glucose	15-minute average glucose assessed by CGM in the fasted state upon awakening	Average of the three days during each intervention