Glucose IntoleranceGLYCEMIANCT03922685
Effects of Diet and Exercise on Circadian Glycemia
A study testing Dietary manipulation (25% carbohydrate diet) and behavioral (exercise) and Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary) in people with Glucose Intolerance, run by University of Michigan.
Trial summary
Specific aims of the study are: 1. 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 2. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- Dietary manipulation (25% carbohydrate diet) and behavioral (exercise) and Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- metabolic disease other than hormonally-corrected hypothyroidism
- musculo-skeletal disability that would preclude exercise
- smoker
- do not meet inclusion criteria
About this study
Official title: Control of Postprandial Glycemia: the Roles of Diet and Exercise
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.
Read the 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.
- Conditions
- Glucose Intolerance
- Being tested
- Dietary manipulation (25% carbohydrate diet) and behavioral (exercise), Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)Combination product
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
Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Morning sedentary arm | Active comparator | 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. Receives: Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary) |
| Morning exercise arm | Active comparator | 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. Receives: Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (exercise) |
| Evening sedentary arm | Active comparator | 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. Receives: Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary) |
| Evening exercise arm | Active comparator | 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. Receives: Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose concentration
The area under the postprandial glucose curve
Measured: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Postprandial insulin concentration
The area under the postprandial insulin curve
Measured: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Secondary outcomes (3)
Postprandial glucose-dependent insulinotropic peptide (GIP) concentration
The area under the postprandial GIP curve
Measured: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Postprandial beta-hydroxybutyrate concentration
The area under the beta-hydroxybutyrate postprandial curve
Measured: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Postprandial leptin concentration
The area under the leptin postprandial curve
Measured: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Sep 2016
- Primary completion31 Aug 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Michigan University
- Responsible party
- Principal investigator, Dr. Katarina Borer, University of Michigan
- Investigators
- Katarina T Borer, Ph.D., Principal investigator, Professor Emerita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922685
- Sponsor's protocol ID
- HUM00110793
- Acronym
- GLYCEMIA
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Postprandial Glycemia: the Roles of Diet and Exercise
- ClinicalTrials.gov ID
- NCT03922685
- Acronym / sponsor ID
- GLYCEMIA / HUM00110793
- Conditions
- Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Northern Michigan University
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Morning sedentary arm | Active comparator | Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)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. |
| Morning exercise arm | Active comparator | Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)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. |
| Evening sedentary arm | Active comparator | Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)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. |
| Evening exercise arm | Active comparator | Combination Product: Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- postmenopausal
- normal blood glucose
- no cholesterol medication
- age between 50 an 65 years
- overweight but not obese
Key exclusion criteria (4 listed)
- metabolic disease other than hormonally-corrected hypothyroidism
- musculo-skeletal disability that would preclude exercise
- smoker
- do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)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 | Combination product | Evening exercise arm, Morning exercise arm |
| Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)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. | Combination product | Evening sedentary arm, Morning sedentary arm |
Primary outcome
Postprandial glucose concentration
Time frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
The area under the postprandial glucose curve
Postprandial insulin concentration
Time frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
The area under the postprandial insulin curve
3 secondary outcomes
Postprandial glucose-dependent insulinotropic peptide (GIP) concentration
Time frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Postprandial beta-hydroxybutyrate concentration
Time frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Postprandial leptin concentration
Time frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers
Related trials for Glucose Intolerance
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarina T Borer, Ph.D. principal investigator
Professor Emerita
Questions about this trial
What is this clinical trial studying?
A study testing Dietary manipulation (25% carbohydrate diet) and behavioral (exercise) and Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary) in people with Glucose Intolerance, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose concentration (time frame: Four hours: 19:20 to 23:20 in the evening trials; 7:20 to 11:20 in the morning trials). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.