Predictive markers of gestational diabetes mellitus in first and early second trimester of pregnancy

• Register: ISRCTN
• Last refreshed on: 12 November 2018
• Main ID: ISRCTN13134709
• Date of registration: 20/03/2017
• Prospective Registration: Yes
• Primary sponsor: University of Athens
• Public title: Predictive markers of gestational diabetes mellitus in first and early second trimester of pregnancy
• Scientific title: Adiponectin, leptin, sex hormone-binding globulin (SHBG) and lipid profile values during the first or early second trimester of pregnancy and the subsequent risk of gestational diabetes mellitus later in pregnancy
• Date of first enrolment: 01/04/2017
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN13134709
• Study type: Observational
• Study design: Single-centre case-control study (Screening)

Countries of recruitment

Greece

Contacts

• Name: Georgios Daskalakis

• Name: Georgios Asimakopoulos

Key inclusion & exclusion criteria

Inclusion criteria: 1. Female
2. Age over 18 years
3. Singleton pregnancies
Exclusion criteria: 1. Age under 18 years
2. Multiple pregnancy
3. Pre-existing type 1 or type 2 diabetes mellitus
4. Chronic hypertension
5. Preeclampsia, eclampsia
6. Hypothyroidism
7. Pre-existing renal or hepatic impairment
8. Other chronic diseases (e.g. valvular heart disease)
9. Vaginal bleeding (e.g. placental abruption)
10. Special diets (e.g. lactose intolerance)
11. Inadequate monitoring during pregnancy

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Gestational diabetes mellitus
Pregnancy and Childbirth
Gestational diabetes mellitus

Intervention(s)

At 11 - 13 (plus six days) weeks of pregnancy, blood samples from pregnant participants are collected and stored at -80 C.

At 24 to 28 weeks of gestation, according to the results of the 2 hour 75 gr Oral Glucose Tolerance Test (OGTT), two groups of 75 participants per group are formed. The glucose test is done to diagnose gestational diabetes and determine who is in the case or the control groups. The test involves participants giving a blood sample prior to eating or drinking, drinking a sugary drink and then giving another blood sample to see how the body can handle to sugar. Participants whose pregnancies are complicated with gestational diabetes are allocated to group one (the case group). Participants with normal pregnancies are allocated to group two (the control group). The target number of participants for each group is obtained using statistical analysis.

The stored blood samples of those two groups are analysed for the quantitative determination of serum adiponectin, leptin, SHBG and lipid profile (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol). The measurements of lipid profile are also be used for the determination of the atherogenic markers LDL cholesterol, HDL cholesterol, triglycerides, HDL cholesterol and total cholesterol, HDL cholesterol.

The serum measurements of the above first trimester markers of the two groups (case vs control) are recorded in a database and analyzed with the appropriate statistical method.

Primary Outcome(s)

1. Serum adiponectin is measured using blood samples at 11-13 (plus six days) weeks of pregnancy
2. Serum leptin measured using blood samples at 11-13 (plus six days) weeks of pregnancy

Secondary Outcome(s)

1. Serum sex hormone-binding globulin (SHBG) are measured using blood samples at 11-13 (plus six days) weeks of pregnancy
2. Lipid profile (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol) are measured usng blood samples at 11-13 (plus six days) weeks of pregnancy
3. Atherogenic markers (LDL cholesterol, HDL cholesterol, triglycerides, HDL cholesterol and total cholesterol, HDL cholesterol) are measured using blood samples at 11-13 (plus six days) weeks of pregnancy

Secondary ID(s)

N/A

Source(s) of Monetary Support

National and Kapodistrian University of Athens

Ethics review

Status:
Approval date:
Contact:

Scientific Board of Alexandra Hospital, 23/11/2016, ref: 717/09-11-2016

Results

• Results available: Yes
• Date Completed: 31/05/2019