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Effects of Diet and Exercise on Circadian Glycemia (GLYCEMIA)

Primary Purpose

Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)
Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Intolerance

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • postmenopausal
  • normal blood glucose
  • no cholesterol medication
  • age between 50 an 65 years
  • overweight but not obese
  • BMI between 25 and 30 kg/m2
  • weight-stable during past 6 months
  • exercise less than 20 minutes three times a week

Exclusion Criteria:

  • metabolic disease other than hormonally-corrected hypothyroidism
  • musculo-skeletal disability that would preclude exercise
  • smoker
  • do not meet inclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Morning sedentary arm

    Morning exercise arm

    Evening sedentary arm

    Evening exercise arm

    Arm Description

    After arriving at MCRU at 7 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 7:20 h. Over the next 4 hours, subjects reclined on a bed and had 3-ml blood samples collected at 10-min intervals. After the 11:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.

    After arriving at MCRU at 7 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 7:20 h. At 8 h, subjects walked on the treadmill at 50% maximal effort. Between 7:20 and 11:20, 3-ml blood samples were collected at 10-min intervals.After the 11:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.

    After arriving at MCRU at 19 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 19:20 h. Over the next 4 hours, subjects reclined on a bed and had 3-ml blood samples collected at 10-min intervals. After the 23:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.

    After arriving at MCRU at 19 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 19:20 h. At 8 h, subjects walked on the treadmill at 50% maximal effort. Between 19:20 and 23:20, 3-ml blood samples were collected at 10-min intervals.After the 23:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.

    Outcomes

    Primary Outcome Measures

    Postprandial glucose concentration
    The area under the postprandial glucose curve
    Postprandial insulin concentration
    The area under the postprandial insulin curve

    Secondary Outcome Measures

    Postprandial glucose-dependent insulinotropic peptide (GIP) concentration
    The area under the postprandial GIP curve
    Postprandial beta-hydroxybutyrate concentration
    The area under the beta-hydroxybutyrate postprandial curve
    Postprandial leptin concentration
    The area under the leptin postprandial curve

    Full Information

    First Posted
    April 17, 2019
    Last Updated
    April 17, 2019
    Sponsor
    University of Michigan
    Collaborators
    Northern Michigan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03922685
    Brief Title
    Effects of Diet and Exercise on Circadian Glycemia
    Acronym
    GLYCEMIA
    Official Title
    Control of Postprandial Glycemia: the Roles of Diet and Exercise
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    August 31, 2017 (Actual)
    Study Completion Date
    April 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    Northern Michigan University

    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
    Specific aims of the study are: to evaluate whether a 24-h exposure to a 25%-carbohydrate diet will reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h),. and to determine whether one hour of post-meal moderate intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia. The outcome measures are: plasma concentrations of glucose, insulin, glucose-dependent-insulinotropic peptide (GIP), leptin, and the ketone body beta-hydroxybutyrate.
    Detailed Description
    The two hypotheses in this study are: A 24-h exposure to a 25%-carbohydrate diet will reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h), and One hour of moderate-intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h). Eight postmenopausal subjects (age 58.5 years, BMI 25.6 kg/m2) participated in 4 24-h long crossover trials, two terminating at 7h and the other 2 at 19h. At each circadian time one trial required 60 minutes of moderate-intensity exercise (50% of maximal effort), and the other two involved no exercise. Three 25%-carbohydrate meals prepared by the Michigan Clinical Research Unit (MCRU) kitchen, were eaten at subjects' home, and the fourth was eaten 20 minutes after subjects' arrival at MCRU at either 19 h or 7 h. Blood was collected from antecubital catheter at 10-minute intervals until 23:20 h or 11:20 h, respectively.Plasma was treated with protease inhibitor to preserve GIP, frozen at -80o C until glucose measurements by glucose oxidase, hormone measurements by chemiluminescence, and ketone measurements by Abbott meter strips. Exercise intensity was determined before the exercise trials on a treadmill from oxygen consumption (VO2) and carbon dioxide production (VCO2) by subjects walking on a treadmill at 3 mph with the treadmill slope increased by 2% every 3 minutes. Maximal effort was established when respiratory exchange ratio (VCO2/VO2) reached or exceeded 1. The treadmill speed and slope at half maximal effort was used during the one-hour exercise bout which was initiated 40 minutes after the start of the meal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glucose Intolerance

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    The same eight subjects participated in counterbalanced order in: (1) sedentary morning trial, (2) exercise morning trial, (3) sedentary evening trial, (4) exercise evening trial.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Morning sedentary arm
    Arm Type
    Active Comparator
    Arm Description
    After arriving at MCRU at 7 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 7:20 h. Over the next 4 hours, subjects reclined on a bed and had 3-ml blood samples collected at 10-min intervals. After the 11:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.
    Arm Title
    Morning exercise arm
    Arm Type
    Active Comparator
    Arm Description
    After arriving at MCRU at 7 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 7:20 h. At 8 h, subjects walked on the treadmill at 50% maximal effort. Between 7:20 and 11:20, 3-ml blood samples were collected at 10-min intervals.After the 11:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.
    Arm Title
    Evening sedentary arm
    Arm Type
    Active Comparator
    Arm Description
    After arriving at MCRU at 19 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 19:20 h. Over the next 4 hours, subjects reclined on a bed and had 3-ml blood samples collected at 10-min intervals. After the 23:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.
    Arm Title
    Evening exercise arm
    Arm Type
    Active Comparator
    Arm Description
    After arriving at MCRU at 19 h, and having eaten three 25%-carbohydrate meals over the previous 24 h, subjects had an antecubital-vein catheter inserted and consumed their fourth 25%-carbohydrate meal at 19:20 h. At 8 h, subjects walked on the treadmill at 50% maximal effort. Between 19:20 and 23:20, 3-ml blood samples were collected at 10-min intervals.After the 23:20 blood sample, subjects were released from MCRU. This arm is compared to the other three arms.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)
    Intervention Description
    The 25% carbohydrate diet consisted of Pulmocare-vanilla liquid, white roll, butter, and string cheese in proportions to achieve 33% of weigh-maintenance diet containing 25% carbohydrate, 20% protein, and 55% fat. Exercise was walking 1 hour on level treadmill at 50% of maximal effort starting 40 minutes after the beginning of the meal
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)
    Intervention Description
    The 25% carbohydrate diet consisted of Pulmocare-vanilla liquid, white roll, butter, and string cheese in proportions to achieve 33% of weigh-maintenance diet containing 25% carbohydrate, 20% protein, and 55% fat. There was no exercise during this trial.
    Primary Outcome Measure Information:
    Title
    Postprandial glucose concentration
    Description
    The area under the postprandial glucose curve
    Time Frame
    Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
    Title
    Postprandial insulin concentration
    Description
    The area under the postprandial insulin curve
    Time Frame
    Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
    Secondary Outcome Measure Information:
    Title
    Postprandial glucose-dependent insulinotropic peptide (GIP) concentration
    Description
    The area under the postprandial GIP curve
    Time Frame
    Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
    Title
    Postprandial beta-hydroxybutyrate concentration
    Description
    The area under the beta-hydroxybutyrate postprandial curve
    Time Frame
    Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
    Title
    Postprandial leptin concentration
    Description
    The area under the leptin postprandial curve
    Time Frame
    Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: postmenopausal normal blood glucose no cholesterol medication age between 50 an 65 years overweight but not obese BMI between 25 and 30 kg/m2 weight-stable during past 6 months exercise less than 20 minutes three times a week Exclusion Criteria: metabolic disease other than hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katarina T Borer, Ph.D.
    Organizational Affiliation
    Professor Emerita
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to share individual participant data with other researchers

    Learn more about this trial

    Effects of Diet and Exercise on Circadian Glycemia

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