Treating Prediabetes in the First Trimester

NCT01926457 | Completed DMC

• 1 other identifier: UCSD-GDM-RCT
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• Umbilical Cord C-Peptide >90th percentile

  1 day (Collected at the time of delivery)

Secondary Outcomes (3)

• Neonatal fat mass

  Within 48 hours of delivery

• Adherence to the Institute of Medicine (IOM) guidelines for gestational weight gain

  Weight gain will be measured from immediately preconception until delivery

• Return to prepregnancy weight

  After 1 year post delivery

Other Outcomes (13)

• birthweight

  At delivery

• birthweight percentile

  At delivery

• Infant gender

  At delivery

Study Arms (2)

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

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

Other: Treatment of Prediabetes

Interventions

Treatment of Prediabetes OTHER

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

First Trimester Treatment of Prediabetes; Third Trimester Treatment of Prediabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• American College of Obstetricians and Gynecologists: collaborator
• Society for Maternal-Fetal Medicine: collaborator

Study Sites (1)

UC San Diego Health System

San Diego, California, 92103, United States

Location

Related Publications (16)

• 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.

  PMID: 19011170 BACKGROUND

• HAPO 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.

  PMID: 18463375 BACKGROUND

• Catalano 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.

  PMID: 14710101 BACKGROUND

• Kim 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.

  PMID: 23000698 BACKGROUND

• Catalano 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.

  PMID: 22357187 BACKGROUND

• Hedderson 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.

  PMID: 20177292 BACKGROUND

• International 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.

  PMID: 20190296 BACKGROUND

• Catalano 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.

  PMID: 7485315 BACKGROUND

• Riskin-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.

  PMID: 19549728 BACKGROUND

• Persson 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.

  PMID: 6751089 BACKGROUND

• Lappas 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.

  PMID: 22266962 BACKGROUND

• Gillum 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.

  PMID: 22110092 BACKGROUND

• Banks 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.

  PMID: 18840364 BACKGROUND

• Astapova 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.

  PMID: 23017715 BACKGROUND

• Qiao 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.

  PMID: 22872236 BACKGROUND

• Luo ZC, Nuyt AM, Delvin E, Fraser WD, Julien P, Audibert F, Girard I, Shatenstein B, Deal C, Grenier E, Garofalo C, Levy E. Maternal and fetal leptin, adiponectin levels and associations with fetal insulin sensitivity. Obesity (Silver Spring). 2013 Jan;21(1):210-6. doi: 10.1002/oby.20250.

  PMID: 23505188 BACKGROUND

Related Links

• The American Association of Obstetricians and Gynecologists Foundation
• UC San Diego Health System Department of Reproductive Medicine

MeSH Terms

Conditions

Prediabetic State; Diabetes, Gestational; Gestational Weight Gain; Pediatric Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders

Study Officials

• Hilary A Roeder, MD

  UC San Diego Health System

  PRINCIPAL INVESTIGATOR

• Gladys A Ramos, MD

  UC San Diego Health System

  PRINCIPAL INVESTIGATOR

• Thomas R Moore, MD

  UC San Diego Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physican, Clinical Instructor, Maternal-Fetal Medicine

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 21, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 15, 2017
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

US (1)