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Insulin ResistanceIRRMNCT02705248

Insulin Resistance in Recurrent Miscarriage

An observational study of Insulin Resistance, run by Ain Shams Maternity Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 23 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Insulin Resistance
How many people
80 participants
Where
No sites listed yet
Study dates
Dec 2013to Mar 2016
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: pregnant females in their first trimester (6- 13 weeks Gestational Age)

Who may be able to join

  • 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)

Who cannot join

  • 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).

About this study

Official title: The Role of Insulin Resistance in Recurrent Miscarriage

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

Read the 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:
  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.

Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02705248
Study groupRoleWhat they receive
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 Bcontrol group: 40 pregnant females at 6- 13wks with no history of abortion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: first trimester of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2016 (estimated)
  2. Study startDec 2013
  3. Primary completionJun 2014
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
80 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT02705248
Sponsor's protocol ID
AinShamsMH 1
Acronym
IRRM
Status last verified
Mar 2016
First submitted
7 Mar 2016
Last updated
10 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Insulin Resistance, run by Ain Shams Maternity Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

insulin resistance in patients with recurrent miscarriage (time frame: first trimester of pregnancy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.

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