Gestational Diabetes MellitusNCT01171456
Early Intervention for Gestational Diabetes
A study testing Metformin in people with Gestational Diabetes Mellitus, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Gestational diabetes (GDM) represents a significant and growing source nationwide of morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are complicated by GDM. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2010
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women delivered >37 weeks gestation in the Intermountain Healthcare Urban Central Region within the last 18 months to ascertain those at risk for GDM in their next pregnancy because of:
- A history of gestational diabetes in their immediately prior pregnancy
- A family history (i.e. type 2 diabetes in a first or second degree relative) of type 2 diabetes
- Delivery of an infant > 4000 gms.
- B.M.I. > 30 six months postpartum
- Hemoglobin A1C > 6.1% six months postpartum
Who cannot join
- Pre-conception exclusion criteria will include any of the following:
- History of >1 miscarriage or fetal demise
- No contraindication to metformin (prior metformin intolerance, metabolic acidosis, GI disease)
- Hypertension (BP >135/85)
- No other endocrine, metabolic, renal, or autommune medical disorders
- Prior preterm birth
Show all 13Show fewer
- Prior delivery complicated by shoulder dystocia
- Prior delivery complicated by neonatal palsy
- Multifetal pregnancy, including first-trimester embryonic demise of one or more
- Uterine malformations
- Illicit drug or alcohol abuse during current pregnancy
- Intent to deliver elsewhere
- Non-availability for prospective specimen/data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Medical Intervention in Women at Risk for Gestational Diabetes
Gestational diabetes (GDM) represents a significant and growing source nationwide of morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are complicated by GDM. Infants exposed in utero to hyperglycemia from GDM have an increased risk of neonatal complications as well as an increased prevalence of a number of chronic diseases, including type 2 diabetes and schizophrenia. Recent research shows that treatment with metformin begun as soon as hyperglycemia is detected in pregnancy is safe and effective. Additional studies demonstrated that metformin is able to decrease the incidence of type 2 diabetes among individuals at risk for this disease. Based upon these findings, the investigators propose to test the hypothesis that metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.
The investigators intend to conduct a prospective, randomized, double-blind placebo controlled range-finding study to measure the effects of early metabolic intervention with metformin in women at risk for GDM before the commencement of pregnancy or prior to completion of the first trimester. The target sample size for this pilot study is 100 women. The effect size observed will provide preliminary data for a subsequent study which will be sufficiently powered to detect small or moderate effects from early metabolic intervention in women at risk for GDM.
Read more
The specific aims of the proposed research consist of the following:
- Determine whether treating women at risk for GDM with metformin prior to conception and/or completion of the 1st trimester decreases the incidence of GDM at 26 weeks' gestation.
- Evaluate the effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin in women at risk for GDM.
- Use these pilot study results to:
- identify specific demographic characteristics associated with an intervention effect
- calculate effect size for specific outcomes
- provide range-finding data for a subsequent study design
Metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Metformin, Placebo
- Keywords
- GDM, Gestational Diabetes, Diabetes, Pregnancy
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Administration of Metformin or placebo prior to conception to prevent the onset of GDM.
PlaceboDrug
Administration of Metformin or placebo prior to conception to prevent the onset of GDM.
| Study group | Role | What they receive |
|---|---|---|
| Metformin Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Metformin | Active comparator | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of metformin versus placebo on the development of GDM
Measured: Pre-conception to delivery (at 8 week intervals)
Secondary outcomes (1)
Effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin.
Measured: Pre-conception until discharge from hospital after delivery (at 4 week intervals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Insufficient funding for enrollment of patients. The invesitgators realized the study could not be performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ware Branch, Intermountain Health Care, Inc.
- Investigators
- Ware Branch, M.D., Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171456
- Sponsor's protocol ID
- 1017118
- Status last verified
- Jan 2013
- First submitted
- 13 Jul 2010
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Medical Intervention in Women at Risk for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01171456
- Acronym / sponsor ID
- 1017118
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- GDM, Gestational Diabetes, Diabetes, Pregnancy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding for enrollment of patients. The invesitgators realized the study could not be performed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 28 Jul 2010 (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.
Gestational diabetes (GDM) represents a significant and growing source nationwide of morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are complicated by GDM. Infants exposed in utero to hyperglycemia from GDM have an increased risk of neonatal complications as well as an increased prevalence of a number of chronic diseases, including type 2 diabetes and schizophrenia. Recent research shows that treatment with metformin begun as soon as hyperglycemia is detected in pregnancy is safe and effective. Additional studies demonstrated that metformin is able to decrease the incidence of type 2 diabetes among individuals at risk for this disease. Based upon these findings, the investigators propose to test the hypothesis that metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.
The investigators intend to conduct a prospective, randomized, double-blind placebo controlled range-finding study to measure the effects of early metabolic intervention with metformin in women at risk for GDM before the commencement of pregnancy or prior to completion of the first trimester. The target sample size for this pilot study is 100 women. The effect size observed will provide preliminary data for a subsequent study which will be sufficiently powered to detect small or moderate effects from early metabolic intervention in women at risk for GDM.
The specific aims of the proposed research consist of the following:
- Determine whether treating women at risk for GDM with metformin prior to conception and/or completion of the 1st trimester decreases the incidence of GDM at 26 weeks' gestation.
- Evaluate the effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin in women at risk for GDM.
- Use these pilot study results to:
- identify specific demographic characteristics associated with an intervention effect
- calculate effect size for specific outcomes
- provide range-finding data for a subsequent study design
Metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Placebo | Placebo comparator | Drug: Placebo |
| Metformin | Active comparator | Drug: Metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women delivered >37 weeks gestation in the Intermountain Healthcare Urban Central Region within the last 18 months to ascertain those at risk for GDM in their next pregnancy because of:
- A history of gestational diabetes in their immediately prior pregnancy
- A family history (i.e. type 2 diabetes in a first or second degree relative) of type 2 diabetes
- Delivery of an infant > 4000 gms.
- B.M.I. > 30 six months postpartum
Key exclusion criteria (13 listed)
- History of >1 miscarriage or fetal demise
- No contraindication to metformin (prior metformin intolerance, metabolic acidosis, GI disease)
- Hypertension (BP >135/85)
- No other endocrine, metabolic, renal, or autommune medical disorders
- Prior preterm birth
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 |
|---|---|---|
| MetforminAdministration of Metformin or placebo prior to conception to prevent the onset of GDM. | Drug | Metformin |
| PlaceboAdministration of Metformin or placebo prior to conception to prevent the onset of GDM. | Drug | Metformin Placebo |
Primary outcome
Effect of metformin versus placebo on the development of GDM
Time frame: Pre-conception to delivery (at 8 week intervals)
1 secondary outcome
Effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin.
Time frame: Pre-conception until discharge from hospital after delivery (at 4 week intervals)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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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.
Ware Branch, M.D. principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Gestational Diabetes Mellitus, run by Intermountain Health Care, Inc. 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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 16 Jan 2013. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Effect of metformin versus placebo on the development of GDM (time frame: Pre-conception to delivery (at 8 week intervals)). 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 16 Jan 2013.