Role of serum irisin to predict the development of gestational diabetes mellitus

Not Applicable

Completed

• Registration Number: CTRI/2019/09/021379
• Lead Sponsor: Dr Devadarshini Sahoo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

Pregnant female of age 18 â?? 40 years

Gestational age < 12 completed weeks at 1st assessment

Having at least any one of the high risk feature for developing GDM like

Overweight (BMI more tham equal to 23 kg/m2)

Family history of type 2 DM

Polycystic ovary syndrome

Previous history of macrosomic ( >4 kg) or large for gestational age infant (weight > 90 percentile for gestational age)

Previous history of GDM

Exclusion Criteria

Diagnosis of overt DM by any value above the cutoff given by ADA i.e. FPG more than equalto 126 mg/dl; HbA1c more than equal to 6.5%; or 2 hour post 75 grams OGTT value more than equal to 200 mg/dl

Patient having multi-fetal gestation

Patients with

Heart disease

Chronic hypertension or preeclampsia

Autoimmune disease

Haematological disease

Liver disease

Chronic kidney disease

Alcohol and/or drug addiction

Immunosuppressive treatment

Malignant diseases

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive value of serum Irisin levels during early pregnancy and development of GDM between 24th â?? 28th week of pregnancy.Timepoint: Before 12 week weeks-fasting plasma glucose, serum Irisin, 1 hour post OGTT and 2 hour post OGTT plasma glucose. <br/ ><br>Between 24-28 weeks-fasting plasma glucose, serum Irisin, 1 hour post OGTT and 2 hour post OGTT glucose.

Secondary Outcome Measures

Name	Time	Method
Relationship of fasting plasma glucose (FPG) during early pregnancy and the development of GDM during 24th â?? 28th week of pregnancy <br/ ><br>Correlation between FPG and HbA1c during early pregnancy Relationship between HbA1c in early pregnancy and development of GDM during 24th â?? 28th week of pregnancyTimepoint: Before 12 week weeks-fasting plasma glucose,1 hour post OGTT ,2 hour post OGTT plasma glucose,HbA1c <br/ ><br>Between 24-28 weeks-fasting plasma glucose,1 hour post OGTT ,2 hour post OGTT glucose,HbA1c