- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02705248
Insulin Resistance in Recurrent Miscarriage (IRRM)
The Role of Insulin Resistance in Recurrent Miscarriage
Study Overview
Status
Conditions
Detailed 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:
- Women in the child bearing period between 23-40 years.
- All patients were pregnant.
- The gestational age of both groups 6-13 weeks(1st trimester)
Exclusion criteria:
- Patients with history of gestational diabetes.
- The patients on medication that could affect glucose metabolism at the time of the study (as metformin, Pioglitazone,rosiglitazone).
- Patients with other causes of recurrent abortion as (thyroid dysfunction, uterine anomalies, chromosomal abnormalities, antiphospholipid antibody syndrome).
- Patients with PCOS in the control group (they have insulin resistance).
- 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women in the child bearing period between 23-40 years.
- All patients were pregnant.
- The gestational age of both groups 6-13 weeks(1st trimester)
Exclusion Criteria:
- Patients with history of gestational diabetes.
- The patients on medication that could affect glucose metabolism at the time of the study (as metformin, Pioglitazone,rosiglitazone).
- Patients with other causes of recurrent abortion as (thyroid dysfunction, uterine anomalies, chromosomal abnormalities, antiphospholipid antibody syndrome).
- Patients with PCOS in the control group (they have insulin resistance).
- Obese patients (BMI >30).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Group A
(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) (ASRM, 2008).
|
Group B
control group: 40 pregnant females at 6- 13wks with no history of abortion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
insulin resistance in patients with recurrent miscarriage
Time Frame: first trimester of pregnancy
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tarek M Tamara, Dr, Ain Shams Maternity Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AinShamsMH 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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