Insulin Resistance in Recurrent Miscarriage

Insulin Resistance Clinical Trial

— IRRM  

Official title:

The Role of Insulin Resistance in Recurrent Miscarriage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705248
• Other study ID #: AinShamsMH 1
• Status: Completed
• Phase: N/A
• First received: March 7, 2016
• Last updated: March 9, 2016
• Start date: December 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of this study is to study the association between insulin resistance and recurrent spontaneous miscarriage (RSM).

Description:

This a case-control study which was performed during the period from (December 2013) till (June 2014). Researcher had 80 participants presented to the outpatient clinic in Ain Shams University Maternity hospital; they were classified into two groups: (Group A) case group: 40 pregnant females at 6- 13wks presenting with a history of recurrent pregnancy loss (two or more failed clinical pregnancies as documented by ultrasonography or histopathology examination according to the American Society of Reproductive Medicine). (Group B) control group: 40 pregnant females at 6- 13wks with no history of abortion. They were selected according to inclusion and exclusion criteria:

• Inclusion criteria:

1. Women in the child bearing period between 23-40 years.

2. All patients were pregnant.

3. The gestational age of both groups 6-13 weeks(1st trimester)

• Exclusion criteria:

1. Patients with history of gestational diabetes.

2. The patients on medication that could affect glucose metabolism at the time of the study (as metformin, Pioglitazone,rosiglitazone).

3. Patients with other causes of recurrent abortion as (thyroid dysfunction, uterine anomalies, chromosomal abnormalities, antiphospholipid antibody syndrome).

4. Patients with PCOS in the control group (they have insulin resistance).

5. Obese patients (BMI >30).

The study was conducted after approval of the hospital ethical committee and a written consent was taken from all cases and controls participating in the study after full explanation. For all participants detailed history taking, full examination including body mass index was taken. The subjects were asked to go on a normal diet for 3 days prior to oral glucose tolerance test (OGTT). A fast for 8-10 h was required prior to sampling. A venous blood sample was drawn on the following morning from each subject to determine the concentrations of fasting glucose (FG) and fasting insulin (FI), afterwards subjects were required to drink a mixture of 75 g of pure glucose in 250 ml of water, venous blood samples were drawn again after 1, 2, and 3 h to determine the concentrations of glucose and insulin blood samples for determination of fasting glucose and fasting insulin after 8-10hours fasting and oral glucose tolerance test. Glucose concentration was determined using the hexokinase endpoint method; while insulin concentration was determined using the immunoluminescence method. The Immulite2000 Immunoassay Analyzer was used along with the necessary reagents. The homeostasis model assessment of insulin resistance index (HOMA-IR) for each subject was calculated as follows: [FI (U/ ml) ×FG (mmol/l)]/22.5.The larger the HOMA-IR, the more severe the degree of IR. HOMA-B, which represents the endocrine function of insulin, is calculated as 20× FI/ (FG-3.5). I 60 /I 0 represent the rate of 1-hour insulin to 1-hour glucose, and I60 / G60 represent the rate of 1-hour insulin increase to 1-hour glucose increase. Both values reflect the endocrine functions of B cells of the pancreatic gland. The area under the curve of glucose (AUCG) is equal to half of the FG plus

1-hour glucose, 2-hour glucose, and half of the 3-hour glucose. The area under the curve of insulin (AUCI) is also computed in this manner for insulin. The ratio AUCI/AUCG represents the rate of AUCI to AUCG, and the higher the rate, the more severe the degree of IR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Women in the child bearing period between 23-40 years.

2. All patients were pregnant.

3. The gestational age of both groups 6-13 weeks(1st trimester)

Exclusion Criteria:

1. Patients with history of gestational diabetes.

2. The patients on medication that could affect glucose metabolism at the time of the study (as metformin, Pioglitazone,rosiglitazone).

3. Patients with other causes of recurrent abortion as (thyroid dysfunction, uterine anomalies, chromosomal abnormalities, antiphospholipid antibody syndrome).

4. Patients with PCOS in the control group (they have insulin resistance).

5. Obese patients (BMI >30).

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Abortion, Habitual
• Insulin Resistance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance in patients with recurrent miscarriage	Insulin resistance was determined by measuring fasting Insulin, Fasting glucose, OGTT for all patients. the homeostasis model assessment of insulin resistance index (HOMA-IR) for each subject was calculated	first trimester of pregnancy	Yes