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Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03207269
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Dietary Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A High-protein Bedtime Snack to Control Morning Blood Glucose
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High protein no carbohydrate
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.
Other: Dietary
Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.

Active Comparator: High protein carbohydrate containing
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.
Other: Dietary
Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.

No Intervention: Control no snack
No snack will be consumed prior to bed.



Primary Outcome Measures :
  1. Fasting Plasma glucose [ Time Frame: Day 4 ]
    Fasting Plasma glucose


Secondary Outcome Measures :
  1. 24 h mean blood glucose [ Time Frame: Average of three days during each intervention ]
    continuous blood glucose monitoring

  2. postprandial glucose [ Time Frame: Average of three days during each intervention ]
    breakfast AUC

  3. Fasting insulin [ Time Frame: Average of three days during each intervention ]
    Fasting plasma insulin

  4. Fasting homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: Day 4 ]
    Calculated by fasting plasma glucose and insulin

  5. Overnight blood glucose [ Time Frame: Average of three days during each intervention ]
    Glucose assessed during sleep by continuous glucose monitoring

  6. Fasting continuous glucose monitoring glucose [ Time Frame: Average of the three days during each intervention ]
    15-minute average glucose assessed by CGM in the fasted state upon awakening



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207269


Locations
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Canada, British Columbia
University of British Columbia, Okanagan.
Kelowna, British Columbia, Canada, V1V 1V7
Sponsors and Collaborators
University of British Columbia

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Responsible Party: Jonathan Little, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03207269     History of Changes
Other Study ID Numbers: H17-01055
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases