Late Gestational Diabetes Mellitus Diagnosis in Obese Women

Obesity Clinical Trial

Official title:

Late Gestational Diabetes Mellitus Diagnosis in Obese Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05510518
• Other study ID #: 0115-22-NHR
• Status: Not yet recruiting
• Start date: August 2022
• Est. completion date: February 2025

Study information

• Verified date: August 2022
• Source: Western Galilee Hospital-Nahariya
• Contact: Maya Wolf, MD
• Phone: +972-2-9107186
• Email: MayaW[@]gmc.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the current work, we aim to perform a prospective study that will investigate the relationship between maternal obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) with a late GDM diagnosis (>32 weeks), with an emphasis on obstetric and neonatal outcomes.

Description:

Methods

Study design:

A prospective study that will evaluate the rate of diagnosis of late GDM and clinical effect of performing a repeat OGTT beyond week 32 in women with obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) for whom loading sugar was normal in the second trimester. The study will be carried out in the Mother and Fetus Unit at the Galilee Medical Center in Nahariya, Israel.

Study population:

Target population: women hospitalized in the Mother and Fetus Unit for various reasons, e.g., premature labor, amniotic fluid leakage, reduced fetal movements, following a car accident, etc.

Inclusion criteria:

1. Women with normal OGTT at weeks 24-28

2. Women with BMI >30 kg/m2

Exclusion criteria:

1. Twins

2. Fetal abnormalities

3. Women who received steroids within the preceding week We will invite women who meet the enrollment criteria to participate in the study, and perform an OGTT.

Research objectives:

1. Primary endpoints:

The percentage of obese women with late GDM diagnosis will be divided into two groups according to BMI:

• BMI 30-35 kg/m2

• BMI >35 kg/m2

2. Secondary endpoints:

• Differences in the following obstetric outcomes between women diagnosed or not diagnosed with GDM: percentage of macrosomia, delivery method, shoulder dystocia, grade 3-4 tear

• Differences in the following newborn outcomes between women diagnosed or not diagnosed with GDM: hypoglycemia, jaundice, need for phototherapy, polycythemia, hospitalization in neonatal intensive care, Apgar score, and newborn pH

Research procedure, interpretation of results, and patient follow-up:

• The OGTT involves assessing fasting blood glucose, drinking a solution comprising 100 g of glucose, and three glucose tests at one, two, and three hours following glucose load.

• Interpretation of the OGTT result is performed according to Carpenter-Coustan criteria [6]

• Women who are not diagnosed with GDM will be discharged for continued follow-up for regular prenatal care and the reason for her hospitalization.

• Per standard of care (regardless of research involvement) women diagnosed with GDM will receive counseling by a dietitian and other key department staff and undergo a complete glucose curve (seven tests per day: fasting, before each of three meals, and two hours after each meal).

• If more than 30% of glucose tests are abnormal, the patient will receive standard drug treatment.

• Follow-up is usually performed for 1-2 days in the hospital ward, after which women are discharged to ambulatory follow-up at the Mother and Fetus Clinic of the medical center.

Statistical analysis:

The sample size was calculated using the chi square formula for comparing two groups.

In a previous study in which repeat OGTT was performed beyond week 32 after initially normal results at week 24-28, the diagnosis rate of GDM for the total sample was 10%. An effect size of 20% was considered significant between obese and morbidly obese women with alpha=0.05, power 80%. The calculated sample size was 124 (at least 62 obese and 62 morbidly obese women).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Women with normal OGTT at weeks 24-28

2. Women with BMI >30 kg/m2

Exclusion Criteria:

1. Multiple pregnancy

2. Fetal defects

3. Women who received steroids within the preceding week

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Dystocia
• Fetal Macrosomia
• Gestational Diabetes Mellitus in Pregnancy
• Hypoglycemia
• Hypoglycemia Neonatal
• Jaundice
• Jaundice, Neonatal
• Macrosomia, Fetal
• Neonatal Jaundice
• Obesity
• Obesity, Morbid
• Polycythemia
• Pregnancy in Diabetics
• Shoulder Dystocia

Intervention

Diagnostic Test:
• oral glucose tolerance test (OGTT)
• The OGTT involves assessing fasting blood glucose, drinking a solution comprising 100 g of glucose, and three glucose tests at one, two, and three hours following glucose load.

Locations

Country	Name	City	State
Israel	Galil Medical Center	Nahariyya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (7)

Abu Shqara R, Or S, Wiener Y, Lowenstein L, Frank Wolf M. Clinical implications of the 100-g oral glucose tolerance test in the third trimester. Arch Gynecol Obstet. 2022 Mar 28. doi: 10.1007/s00404-022-06520-5. [Epub ahead of print] — View Citation

Arabin B, Stupin JH. Overweight and Obesity before, during and after Pregnancy: Part 2: Evidence-based Risk Factors and Interventions. Geburtshilfe Frauenheilkd. 2014 Jul;74(7):646-655. — View Citation

Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. — View Citation

Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8. — View Citation

Harrison RK, Cruz M, Wong A, Davitt C, Palatnik A. The timing of initiation of pharmacotherapy for women with gestational diabetes mellitus. BMC Pregnancy Childbirth. 2020 Dec 11;20(1):773. doi: 10.1186/s12884-020-03449-y. — View Citation

Kandauda C, Wanasinghe W. Repeat OGTT at 34 - 36 weeks to detect the late occurrence of GDM: A descriptive cross-sectional study conducted at the professorial unit, teaching hospital Peradeniya, Sri Lanka. Adv Reproduct Sci. 2020;8:157-65.

Zilberberg E, Mazaki S, Zilberman N, Mazkereth R, Weisz B, Sivan E, et al. Should late third trimester oral glucose tolerance test be offered for patients with suspected macrosomia or polyhydramnios? Evidence in support of the clinical importance of this policy. Am J Obstet Gynecol. 2012;206(1):S122.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of obese women that will be diagnosed with late GDM diagnosis by the OGTT	The percentage of obese women with late GDM diagnosis will be analyzed per BMI group: BMI 30-35 kg/m2; BMI >35 kg/m2	through study completion, an average of 1 year
Secondary	neonatal macrosomia rate		From admission to discharge, up to 1 week
Secondary	neonatal hypoglycemia rate		From neonatal admission to discharge, up to 1 week
Secondary	neonatal hospitalization in intensive care rate		From neonatal admission to discharge, up to 4 week