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Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of British Columbia, Okanagan.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

High protein no carbohydrate

High protein carbohydrate containing

Control no snack

Arm 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.

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.

No snack will be consumed prior to bed.

Outcomes

Primary Outcome Measures

Fasting Plasma glucose
Fasting Plasma glucose

Secondary Outcome Measures

24 h mean blood glucose
continuous blood glucose monitoring
postprandial glucose
breakfast AUC
Fasting insulin
Fasting plasma insulin
Fasting homeostasis model assessment of insulin resistance (HOMA-IR)
Calculated by fasting plasma glucose and insulin
Overnight blood glucose
Glucose assessed during sleep by continuous glucose monitoring
Fasting continuous glucose monitoring glucose
15-minute average glucose assessed by CGM in the fasted state upon awakening

Full Information

First Posted
June 30, 2017
Last Updated
November 5, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03207269
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High protein no carbohydrate
Arm Type
Experimental
Arm 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.
Arm Title
High protein carbohydrate containing
Arm Type
Active Comparator
Arm 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.
Arm Title
Control no snack
Arm Type
No Intervention
Arm Description
No snack will be consumed prior to bed.
Intervention Type
Other
Intervention Name(s)
Dietary
Intervention Description
Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.
Primary Outcome Measure Information:
Title
Fasting Plasma glucose
Description
Fasting Plasma glucose
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
24 h mean blood glucose
Description
continuous blood glucose monitoring
Time Frame
Average of three days during each intervention
Title
postprandial glucose
Description
breakfast AUC
Time Frame
Average of three days during each intervention
Title
Fasting insulin
Description
Fasting plasma insulin
Time Frame
Average of three days during each intervention
Title
Fasting homeostasis model assessment of insulin resistance (HOMA-IR)
Description
Calculated by fasting plasma glucose and insulin
Time Frame
Day 4
Title
Overnight blood glucose
Description
Glucose assessed during sleep by continuous glucose monitoring
Time Frame
Average of three days during each intervention
Title
Fasting continuous glucose monitoring glucose
Description
15-minute average glucose assessed by CGM in the fasted state upon awakening
Time Frame
Average of the three days during each intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of British Columbia, Okanagan.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32204977
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.
Results Reference
derived

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Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

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