Gestational Diabetes Mellitus as Antepartum ConditionNCT02149992
Glycemic Impact of Myo-inositol in Pregnancy
A study testing myo-inositol, Continuous glucose monitoring surveillance and Glucose monitoring in people with Gestational Diabetes Mellitus as Antepartum Condition, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European studies. It is not known exactly how this occurs or what it does to the sugar when the supplement is taken. Read more about this study
- Who is it for?
- Ages 13 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus as Antepartum Condition
- What is being tested?
- myo-inositol, Continuous glucose monitoring surveillance and Glucose monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2016
- 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 13 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English-speaking
- singleton
- pregnant females between 20-28 weeks of gestation at time of enrollment PLUS (either of the following)
- High risk including women must have passed routine glucose screening and have greater than or equal to 1 of the following high risk criteria: first degree family member with diabetes mellitus, previous pregnancy with gestational diabetes, PCOS, or body mass index great than or equal to 30.
- Gestational diabetes diagnosed in current pregnancy based on IADPSG or NIH consensus diagnostic recommendation
Who cannot join
- pre-pregnancy diagnosis of diabetes mellitus
- renal disease
- immunocompromised
- currently taking immunosuppressive medications
- age <13 years old
- non-English speaking
- multifetal gestation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Amy M Valent, DO, 503-502-7220, valent@ohsu.edu
Amy M Valent, DO
About this study
Official title: Glycemic Impact of Myo-inositol in High Risk and Gestational Diabetic Pregnancies: a Pilot Study
Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European studies. It is not known exactly how this occurs or what it does to the sugar when the supplement is taken. This study purpose is to look at the patient's sugar levels while taking the supplement to see if the overall levels of sugar go down. We hypothesize that in addition to sugar levels, other hormones influencing diabetes will be altered.
Read the detailed description
Myo-inositol is important for glucose homeostasis and has been shown to improve insulin sensitivity. This is a prospective cohort pilot study to determine daily glycemic pharmacokinetics and metabolic influences of myo-inositol supplementation using continuous glucose monitoring system (CGMS) and pre- and post-supplement blood work in high risk pregnancies and women diagnosed with gestational diabetes mellitis (GDM). Risk factors include: obesity, previous pregnancy with GDM, family history of diabetes, glucose intolerance, and polycystic ovarian syndrome (PCOS). Women will have a CGMS device placed on day one and begin with 3 days of placebo plus folic acid (400mcg) to determine baseline glycemia and metabolic levels. For the final 4 days, women with take myo-inositol supplementation (4g) plus folic acid (400mcg). The CGMS device will be removed on day 7 when final blood work will be obtained. Self-capillary glucose testing 4 times per day is recorded to calibrate CGMS glucose values. These observations will help determine the effects of myo-inositol on overall mean glucose and other metabolic factors in high risk and GDM patients, identify pharmacokinetic discipline in pregnancy, and develop the groundwork for future prospective clinical trials for the prevention and/or augmentation in treatment GDM.
- Being tested
- myo-inositol, Continuous glucose monitoring surveillance, Glucose monitoring
- Keywords
- gestational diabetes, myoinositol
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myo-inositolDietary supplement
Also called Inositol
myo-inositol, oral, 2g, twice a day for 5 days total
Continuous glucose monitoring surveillanceDevice
Also called Medtronic CGMS
monitoring device will be placed by experienced research members to the patient on Day 1 and she will continue to wear until Day 7. This device monitors overall glycemia every 5 minutes and records the information, which can be downloaded after discontinued.
Glucose monitoringDevice
Also called OneTouch glucose meter, test strips, lancets
patients will use the glucose meter, test strips, and lancets to determine her capillary glucose levels 4 times per day (fasting, and 1 hour post-prandial levels)
| Study group | Role | What they receive |
|---|---|---|
| Myo-inositol, folic acid | Experimental | 1. myo-inositol, oral, 2g, two times per day for 5 total days
2. folic acid, oral 200 micrograms, two times per day for 7 days
3. Continuous Glucose Monitoring Surveillance device for 7 days during study period
4. Capillary glucose monitoring 4 times per day Receives: Dietary Supplement: myo-inositol; Device: Continuous glucose monitoring surveillance; Device: Glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mean glucose
Difference in overall mean glucose with folic acid alone versus myo-inositol+folic acid supplementation; measured by continuous glucose monitoring system started pre-supplementation and continued for 4 days after supplementation.
Measured: 7 days
Secondary outcomes (1)
metabolic differences
Metabolic differences (myo-inositol, chiro-inositol, fasting insulin, c-peptide, and adiponectin) pre and post supplementation.
Measured: 1,4,7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus as Antepartum ConditionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Washington University School of Medicine
- Responsible party
- Principal investigator, Amy Valent, Oregon Health and Science University
- Investigators
- Amy M Valent, DO, Principal investigator, Test Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149992
- Sponsor's protocol ID
- 2014-1676
- Status last verified
- May 2016
- First submitted
- 25 May 2014
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Impact of Myo-inositol in High Risk and Gestational Diabetic Pregnancies: a Pilot Study
- ClinicalTrials.gov ID
- NCT02149992
- Acronym / sponsor ID
- 2014-1676
- Keywords
- gestational diabetes, myoinositol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Duke University, Washington University School of Medicine
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 29 May 2014 (estimated)
- 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.
Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European studies. It is not known exactly how this occurs or what it does to the sugar when the supplement is taken. This study purpose is to look at the patient's sugar levels while taking the supplement to see if the overall levels of sugar go down. We hypothesize that in addition to sugar levels, other hormones influencing diabetes will be altered.
Detailed description
Myo-inositol is important for glucose homeostasis and has been shown to improve insulin sensitivity. This is a prospective cohort pilot study to determine daily glycemic pharmacokinetics and metabolic influences of myo-inositol supplementation using continuous glucose monitoring system (CGMS) and pre- and post-supplement blood work in high risk pregnancies and women diagnosed with gestational diabetes mellitis (GDM). Risk factors include: obesity, previous pregnancy with GDM, family history of diabetes, glucose intolerance, and polycystic ovarian syndrome (PCOS). Women will have a CGMS device placed on day one and begin with 3 days of placebo plus folic acid (400mcg) to determine baseline glycemia and metabolic levels. For the final 4 days, women with take myo-inositol supplementation (4g) plus folic acid (400mcg). The CGMS device will be removed on day 7 when final blood work will be obtained. Self-capillary glucose testing 4 times per day is recorded to calibrate CGMS glucose values. These observations will help determine the effects of myo-inositol on overall mean glucose and other metabolic factors in high risk and GDM patients, identify pharmacokinetic discipline in pregnancy, and develop the groundwork for future prospective clinical trials for the prevention and/or augmentation in treatment GDM.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myo-inositol, folic acid | Experimental | Dietary Supplement: myo-inositol, Device: Continuous glucose monitoring surveillance, Device: Glucose monitoring1. myo-inositol, oral, 2g, two times per day for 5 total days 2. folic acid, oral 200 micrograms, two times per day for 7 days 3. Continuous Glucose Monitoring Surveillance device for 7 days during study period 4. Capillary glucose monitoring 4 times per day |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- English-speaking
- singleton
- pregnant females between 20-28 weeks of gestation at time of enrollment PLUS (either of the following)
- High risk including women must have passed routine glucose screening and have greater than or equal to 1 of the following high risk criteria: first degree family member with diabetes mellitus, previous pregnancy with gestational diabetes, PCOS, or body mass index great than or equal to 30.
- Gestational diabetes diagnosed in current pregnancy based on IADPSG or NIH consensus diagnostic recommendation
Key exclusion criteria (7 listed)
- pre-pregnancy diagnosis of diabetes mellitus
- renal disease
- immunocompromised
- currently taking immunosuppressive medications
- age <13 years old
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 |
|---|---|---|
| myo-inositolAlso: Inositolmyo-inositol, oral, 2g, twice a day for 5 days total | Dietary supplement | Myo-inositol, folic acid |
| Continuous glucose monitoring surveillanceAlso: Medtronic CGMSmonitoring device will be placed by experienced research members to the patient on Day 1 and she will continue to wear until Day 7. This device monitors overall glycemia every 5 minutes and records the information, which can be downloaded after discontinued. | Device | Myo-inositol, folic acid |
| Glucose monitoringAlso: OneTouch glucose meter, test strips, lancetspatients will use the glucose meter, test strips, and lancets to determine her capillary glucose levels 4 times per day (fasting, and 1 hour post-prandial levels) | Device | Myo-inositol, folic acid |
Primary outcome
overall mean glucose
Time frame: 7 days
Difference in overall mean glucose with folic acid alone versus myo-inositol+folic acid supplementation; measured by continuous glucose monitoring system started pre-supplementation and continued for 4 days after supplementation.
1 secondary outcome
metabolic differences
Time frame: 1,4,7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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.
Amy M Valent, DO principal investigator
Test Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myo-inositol, Continuous glucose monitoring surveillance and Glucose monitoring in people with Gestational Diabetes Mellitus as Antepartum Condition, run by Oregon Health and Science University at 1 site in United States.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy M Valent, DO (503-502-7220, valent@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall mean glucose (time frame: 7 days). 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 18 May 2016.