PrediabetesNCT01926457
Treating Prediabetes in the First Trimester
A study testing Treatment of Prediabetes in people with Prediabetes and Gestational Diabetes, run by University of California, San Diego at 1 site in United States.
Trial summary
The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of pregnancy, and patients will be randomized to first trimester or third trimester treatment; the first trimester group will receive… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Gestational Diabetes
- What is being tested?
- Treatment of Prediabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 15 Jun 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women age 18 and above
- Any ethnic background
- English- or Spanish-speaking
- Planned prenatal care/delivery at The University of California, San Diego's Hillcrest Hospital
- Singleton pregnancy
- Prediabetes diagnosed prior to 15w0d with HbA1c 5.7-6.4% or FPG 92-125 mg/dL
Who cannot join
- Known Type 2 Diabetes (T2DM)
- T2DM diagnosed with first trimester screening
- Patients with known maternal/fetal indications for delivery <36w0d
- Patients presenting for care after 15w0d
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Health System
San Diego, California, 92103
About this study
Official title: Treating Prediabetes in the First Trimester: A Randomized Controlled Trial
The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of pregnancy, and patients will be randomized to first trimester or third trimester treatment; the first trimester group will receive intervention immediately upon diagnosis of prediabetes whereas the third trimester group will receive only routine prenatal care until 28 weeks at which time they will receive intervention.
Intervention is defined as:
Read more
- diabetes education
- blood glucose monitoring
- medications as needed
- growth ultrasounds
- antenatal testing
The primary outcome is umbilical cord C-Peptide >90th percentile. Secondary outcomes include neonatal fat mass at delivery, infant weight-for-length at 12 months of age, maternal gestational weight gain, and biomarkers (chemicals) measured in the placenta and the baby's umbilical cord blood.
The investigators hypothesize that women who undergo the above intervention in the first trimester will deliver significantly fewer neonates with umbilical cord C-Peptide >90th percentile, and that the neonates will have lower fat mass, and weight-for-length at 12 months. The investigators further hypothesize that a greater proportion of patients undergoing first trimester intervention will have appropriate maternal gestational weight gain as defined by the Institute of Medicine, and a greater proportion will return to prepregnancy weight within 12 months.
Read the detailed description
The primary aim of the proposed research is to demonstrate that promoting a normoglycemic intrauterine milieu in women with prediabetes diagnosed in the first trimester of pregnancy with a Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL will decrease the accumulation of fetal white adipose tissue and development of infant/child obesity during the first year of life. This project is built upon the hypothesis that pregnant subjects with prediabetes randomized in the first trimester of pregnancy to strict glycemic control and pharmacotherapy as needed will have less fetal adiposity and adverse neonatal outcomes than those who receive the diagnosis of prediabetes but do not initiate care until the third trimester.
In the proposed study, 240 women meeting the above criteria for prediabetes at ≤ 15w0d gestation will be randomized to either first trimester or third trimester treatment. Each group will have diabetes education, initiate blood glucose monitoring, begin pharmacotherapy as needed (per established protocol), undergo growth ultrasounds, and antenatal testing. The first trimester arm will receive the above interventions immediately upon diagnosis of prediabetes whereas the third trimester arm will receive only routine prenatal care until 28 weeks at which time they will begin education and treatment. Both groups will be treated identically from 28 weeks until delivery.
In the 2013 the National Institutes of Health (NIH) Gestational Diabetes (GDM) Consensus Conference, the panel was concerned about adopting criteria that would increase prevalence of GDM (i.e. first trimester treatment) without first demonstrating improved outcomes. The results of this proposed trial, will allow us to fill key research gaps; this is the first prospective trial to evaluate the International Associations of Diabetes in Pregnancy Study Groups (IADPSG) recommendations for screening and diagnosing prediabetes in the first trimester.
Findings from this research will quantify the maternal and neonatal benefits and harms of treating women with prediabetes from early pregnancy. Additionally, the cohort of neonates that will result from this study can be followed into childhood to evaluate whether first trimester treatment has benefits beyond those anticipated at birth and may decrease the long-term incidence of obesity and diabetes.
- Conditions
- Prediabetes, Gestational Diabetes
- Being tested
- Treatment of Prediabetes
- Keywords
- First trimester treatment of prediabetes, First trimester treatment of gestational diabetes, Umbilical cord C-Peptide, Neonatal fat mass, Gestational weight gain, Infant obesity
- Medical subject headings
- Prediabetic State, Diabetes, Gestational, Gestational Weight Gain, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of PrediabetesOther
Standardized treatment of prediabetes per California Diabetes and Pregnancy Program "Sweet Success"
- diabetes education
- blood glucose monitoring
- medications as needed per California Diabetes and Pregnancy established protocol
- growth ultrasounds
- antenatal testing
| Study group | Role | What they receive |
|---|---|---|
| First Trimester Treatment of Prediabetes | Experimental | Patients randomized to first trimester treatment will receive the following intervention immediately initiated upon diagnosis of prediabetes at <15 weeks 0 days gestation
* diabetes education
* blood glucose monitoring
* medications as needed per California Diabetes and Pregnancy established protocol
* growth ultrasounds
* antenatal testing Receives: Other: Treatment of Prediabetes |
| Third Trimester Treatment of Prediabetes | Active comparator | Patients randomized to third trimester treatment will receive the following intervention to be initiated at 28 weeks of gestation
* diabetes education
* blood glucose monitoring
* medications as needed per California Diabetes and Pregnancy established protocol
* growth ultrasounds
* antenatal testing Receives: Other: Treatment of Prediabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Cord C-Peptide >90th percentile
Measured: 1 day (Collected at the time of delivery)
Secondary outcomes (3)
Neonatal fat mass
Neonatal fat mass will be measured using an anthropometric model using weight, length, and flank skinfold thickness.
Measured: Within 48 hours of delivery
Adherence to the Institute of Medicine (IOM) guidelines for gestational weight gain
The IOM recommends that underweight women (BMI<18.5kg/m2) gain 28-40lbs, normal women (BMI 18.5-24.9 kg/m2) gain 25-35lbs, overweight women (BMI 25.0-29.9 kg/m2) gain 15-25lbs and obese women (BMI≥30 kg/m2) gain 11-20 lbs.
Measured: Weight gain will be measured from immediately preconception until delivery
Return to prepregnancy weight
Measured: After 1 year post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine
- Responsible party
- Principal investigator, Hilary Roeder, MD, University of California, San Diego
- Investigators
- Hilary A Roeder, MD, Principal investigator, UC San Diego Health SystemGladys A Ramos, MD, Principal investigator, UC San Diego Health SystemThomas R Moore, MD, Principal investigator, UC San Diego Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926457
- Sponsor's protocol ID
- UCSD-GDM-RCT
- Status last verified
- Oct 2018
- First submitted
- 15 Aug 2013
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
HAPO Study Cooperative Research Group. Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations with neonatal anthropometrics. Diabetes. 2009 Feb;58(2):453-9. doi: 10.2337/db08-1112. Epub 2008 Nov 14.
PubMed 19011170HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375Catalano PM, Thomas A, Huston-Presley L, Amini SB. Increased fetal adiposity: a very sensitive marker of abnormal in utero development. Am J Obstet Gynecol. 2003 Dec;189(6):1698-704. doi: 10.1016/s0002-9378(03)00828-7.
PubMed 14710101Kim SY, Sharma AJ, Callaghan WM. Gestational diabetes and childhood obesity: what is the link? Curr Opin Obstet Gynecol. 2012 Dec;24(6):376-81. doi: 10.1097/GCO.0b013e328359f0f4.
PubMed 23000698Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
PubMed 22357187Hedderson MM, Gunderson EP, Ferrara A. Gestational weight gain and risk of gestational diabetes mellitus. Obstet Gynecol. 2010 Mar;115(3):597-604. doi: 10.1097/AOG.0b013e3181cfce4f.
PubMed 20177292International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
PubMed 20190296Catalano PM, Thomas AJ, Avallone DA, Amini SB. Anthropometric estimation of neonatal body composition. Am J Obstet Gynecol. 1995 Oct;173(4):1176-81. doi: 10.1016/0002-9378(95)91348-3.
PubMed 7485315Riskin-Mashiah S, Younes G, Damti A, Auslender R. First-trimester fasting hyperglycemia and adverse pregnancy outcomes. Diabetes Care. 2009 Sep;32(9):1639-43. doi: 10.2337/dc09-0688. Epub 2009 Jun 23.
PubMed 19549728Persson B, Heding LG, Lunell NO, Pschera H, Stangenberg M, Wager J. Fetal beta cell function in diabetic pregnancy. Amniotic fluid concentrations of proinsulin, insulin, and C-peptide during the last trimester of pregnancy. Am J Obstet Gynecol. 1982 Oct 15;144(4):455-9.
PubMed 6751089Lappas M, Andrikopoulos S, Permezel M. Hypoxanthine-xanthine oxidase down-regulates GLUT1 transcription via SIRT1 resulting in decreased glucose uptake in human placenta. J Endocrinol. 2012 Apr;213(1):49-57. doi: 10.1530/JOE-11-0355. Epub 2012 Jan 19.
PubMed 22266962Gillum MP, Kotas ME, Erion DM, Kursawe R, Chatterjee P, Nead KT, Muise ES, Hsiao JJ, Frederick DW, Yonemitsu S, Banks AS, Qiang L, Bhanot S, Olefsky JM, Sears DD, Caprio S, Shulman GI. SirT1 regulates adipose tissue inflammation. Diabetes. 2011 Dec;60(12):3235-45. doi: 10.2337/db11-0616.
PubMed 22110092Banks AS, Kon N, Knight C, Matsumoto M, Gutierrez-Juarez R, Rossetti L, Gu W, Accili D. SirT1 gain of function increases energy efficiency and prevents diabetes in mice. Cell Metab. 2008 Oct;8(4):333-41. doi: 10.1016/j.cmet.2008.08.014.
PubMed 18840364Astapova O, Leff T. Adiponectin and PPARgamma: cooperative and interdependent actions of two key regulators of metabolism. Vitam Horm. 2012;90:143-62. doi: 10.1016/B978-0-12-398313-8.00006-3.
PubMed 23017715Qiao L, Yoo HS, Madon A, Kinney B, Hay WW Jr, Shao J. Adiponectin enhances mouse fetal fat deposition. Diabetes. 2012 Dec;61(12):3199-207. doi: 10.2337/db12-0055. Epub 2012 Aug 7.
PubMed 22872236
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Prediabetes in the First Trimester: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01926457
- Acronym / sponsor ID
- UCSD-GDM-RCT
- Conditions
- Prediabetes, Gestational Diabetes
- Keywords
- First trimester treatment of prediabetes, First trimester treatment of gestational diabetes, Umbilical cord C-Peptide, Neonatal fat mass, Gestational weight gain, Infant obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 21 Aug 2013 (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.
The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of pregnancy, and patients will be randomized to first trimester or third trimester treatment; the first trimester group will receive intervention immediately upon diagnosis of prediabetes whereas the third trimester group will receive only routine prenatal care until 28 weeks at which time they will receive intervention.
Intervention is defined as:
- diabetes education
- blood glucose monitoring
- medications as needed
- growth ultrasounds
- antenatal testing
The primary outcome is umbilical cord C-Peptide >90th percentile. Secondary outcomes include neonatal fat mass at delivery, infant weight-for-length at 12 months of age, maternal gestational weight gain, and biomarkers (chemicals) measured in the placenta and the baby's umbilical cord blood.
The investigators hypothesize that women who undergo the above intervention in the first trimester will deliver significantly fewer neonates with umbilical cord C-Peptide >90th percentile, and that the neonates will have lower fat mass, and weight-for-length at 12 months. The investigators further hypothesize that a greater proportion of patients undergoing first trimester intervention will have appropriate maternal gestational weight gain as defined by the Institute of Medicine, and a greater proportion will return to prepregnancy weight within 12 months.
Detailed description
The primary aim of the proposed research is to demonstrate that promoting a normoglycemic intrauterine milieu in women with prediabetes diagnosed in the first trimester of pregnancy with a Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL will decrease the accumulation of fetal white adipose tissue and development of infant/child obesity during the first year of life. This project is built upon the hypothesis that pregnant subjects with prediabetes randomized in the first trimester of pregnancy to strict glycemic control and pharmacotherapy as needed will have less fetal adiposity and adverse neonatal outcomes than those who receive the diagnosis of prediabetes but do not initiate care until the third trimester.
In the proposed study, 240 women meeting the above criteria for prediabetes at ≤ 15w0d gestation will be randomized to either first trimester or third trimester treatment. Each group will have diabetes education, initiate blood glucose monitoring, begin pharmacotherapy as needed (per established protocol), undergo growth ultrasounds, and antenatal testing. The first trimester arm will receive the above interventions immediately upon diagnosis of prediabetes whereas the third trimester arm will receive only routine prenatal care until 28 weeks at which time they will begin education and treatment. Both groups will be treated identically from 28 weeks until delivery.
In the 2013 the National Institutes of Health (NIH) Gestational Diabetes (GDM) Consensus Conference, the panel was concerned about adopting criteria that would increase prevalence of GDM (i.e. first trimester treatment) without first demonstrating improved outcomes. The results of this proposed trial, will allow us to fill key research gaps; this is the first prospective trial to evaluate the International Associations of Diabetes in Pregnancy Study Groups (IADPSG) recommendations for screening and diagnosing prediabetes in the first trimester.
Findings from this research will quantify the maternal and neonatal benefits and harms of treating women with prediabetes from early pregnancy. Additionally, the cohort of neonates that will result from this study can be followed into childhood to evaluate whether first trimester treatment has benefits beyond those anticipated at birth and may decrease the long-term incidence of obesity and diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Trimester Treatment of Prediabetes | Experimental | Other: Treatment of PrediabetesPatients randomized to first trimester treatment will receive the following intervention immediately initiated upon diagnosis of prediabetes at <15 weeks 0 days gestation * diabetes education * blood glucose monitoring * medications as needed per California Diabetes and Pregnancy established protocol * growth ultrasounds * antenatal testing |
| Third Trimester Treatment of Prediabetes | Active comparator | Other: Treatment of PrediabetesPatients randomized to third trimester treatment will receive the following intervention to be initiated at 28 weeks of gestation * diabetes education * blood glucose monitoring * medications as needed per California Diabetes and Pregnancy established protocol * growth ultrasounds * antenatal testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women age 18 and above
- Any ethnic background
- English- or Spanish-speaking
- Planned prenatal care/delivery at The University of California, San Diego's Hillcrest Hospital
- Singleton pregnancy
Key exclusion criteria (4 listed)
- Known Type 2 Diabetes (T2DM)
- T2DM diagnosed with first trimester screening
- Patients with known maternal/fetal indications for delivery <36w0d
- Patients presenting for care after 15w0d
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 |
|---|---|---|
| Treatment of PrediabetesStandardized treatment of prediabetes per California Diabetes and Pregnancy Program "Sweet Success" * diabetes education * blood glucose monitoring * medications as needed per California Diabetes and Pregnancy established protocol * growth ultrasounds * antenatal testing | Other | First Trimester Treatment of Prediabetes, Third Trimester Treatment of Prediabetes |
Primary outcome
Umbilical Cord C-Peptide >90th percentile
Time frame: 1 day (Collected at the time of delivery)
3 secondary outcomes
Neonatal fat mass
Time frame: Within 48 hours of delivery
Adherence to the Institute of Medicine (IOM) guidelines for gestational weight gain
Time frame: Weight gain will be measured from immediately preconception until delivery
Return to prepregnancy weight
Time frame: After 1 year post delivery
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 10 Oct 2018.
- Background: PubMed 19011170HAPO Study Cooperative Research Group. Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations with neonatal anthropometrics. Diabetes. 2009 Feb;58(2):453-9. doi: 10.2337/db08-1112. Epub 2008 Nov 14.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 14710101Catalano PM, Thomas A, Huston-Presley L, Amini SB. Increased fetal adiposity: a very sensitive marker of abnormal in utero development. Am J Obstet Gynecol. 2003 Dec;189(6):1698-704. doi: 10.1016/s0002-9378(03)00828-7.
- Background: PubMed 23000698Kim SY, Sharma AJ, Callaghan WM. Gestational diabetes and childhood obesity: what is the link? Curr Opin Obstet Gynecol. 2012 Dec;24(6):376-81. doi: 10.1097/GCO.0b013e328359f0f4.
- Background: PubMed 22357187Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
- Background: PubMed 20177292Hedderson MM, Gunderson EP, Ferrara A. Gestational weight gain and risk of gestational diabetes mellitus. Obstet Gynecol. 2010 Mar;115(3):597-604. doi: 10.1097/AOG.0b013e3181cfce4f.
- Background: PubMed 20190296International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
- Background: PubMed 7485315Catalano PM, Thomas AJ, Avallone DA, Amini SB. Anthropometric estimation of neonatal body composition. Am J Obstet Gynecol. 1995 Oct;173(4):1176-81. doi: 10.1016/0002-9378(95)91348-3.
- Background: PubMed 19549728Riskin-Mashiah S, Younes G, Damti A, Auslender R. First-trimester fasting hyperglycemia and adverse pregnancy outcomes. Diabetes Care. 2009 Sep;32(9):1639-43. doi: 10.2337/dc09-0688. Epub 2009 Jun 23.
- Background: PubMed 6751089Persson B, Heding LG, Lunell NO, Pschera H, Stangenberg M, Wager J. Fetal beta cell function in diabetic pregnancy. Amniotic fluid concentrations of proinsulin, insulin, and C-peptide during the last trimester of pregnancy. Am J Obstet Gynecol. 1982 Oct 15;144(4):455-9.
- Background: PubMed 22266962Lappas M, Andrikopoulos S, Permezel M. Hypoxanthine-xanthine oxidase down-regulates GLUT1 transcription via SIRT1 resulting in decreased glucose uptake in human placenta. J Endocrinol. 2012 Apr;213(1):49-57. doi: 10.1530/JOE-11-0355. Epub 2012 Jan 19.
- Background: PubMed 22110092Gillum MP, Kotas ME, Erion DM, Kursawe R, Chatterjee P, Nead KT, Muise ES, Hsiao JJ, Frederick DW, Yonemitsu S, Banks AS, Qiang L, Bhanot S, Olefsky JM, Sears DD, Caprio S, Shulman GI. SirT1 regulates adipose tissue inflammation. Diabetes. 2011 Dec;60(12):3235-45. doi: 10.2337/db11-0616.
- The American Association of Obstetricians and Gynecologists FoundationLink provided by the sponsor.
- UC San Diego Health System Department of Reproductive MedicineLink provided by the sponsor.
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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.
Hilary A Roeder, MD principal investigator
UC San Diego Health System
Gladys A Ramos, MD principal investigator
UC San Diego Health System
Thomas R Moore, MD principal investigator
UC San Diego Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of Prediabetes in people with Prediabetes and Gestational Diabetes, run by University of California, San Diego 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 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 10 Oct 2018. 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?
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?
Umbilical Cord C-Peptide >90th percentile (time frame: 1 day (Collected at the time of delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01926457, which also lists 16 linked publications.
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 10 Oct 2018.