| CTRI Number |
CTRI/2025/08/092909 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How Body Fat, Fat Burning, and Body reaction to injury Affect blood Sugar Levels and Pregnancy Health in Women with Diabetes in pregnancy and its risk to mother and baby. |
|
Scientific Title of Study
|
Body Fat Indices, Fatty Acid Oxidation capacity and Inflammatory crosstalk in Gestational Diabetes Mellitus: Insights into Insulin Resistance and its impact on Maternal-Fetal Risk. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Melwin Maben |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Madhavnagar Manipal Karnataka India 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9739398302 |
| Fax |
|
| Email |
melwinmaben@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivaprakash G |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Madhavnagar Manipal Karnataka India 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9449553742 |
| Fax |
|
| Email |
shiva.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Melwin Maben |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Madhavnagar Manipal Karnataka India 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9739398302 |
| Fax |
|
| Email |
melwinmaben@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynecology Kasturba Medical College Madhavnagar Manipal Karnataka India 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Kasturba Medical College Madhavnagar Manipal Karnataka India 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Melwin Maben |
Kasturba Medical College |
Obstetrics and Gynecology OPD, Ground Floor, Women and Child Block, Kasturba Hospital, Kasturba Medical College, Madhavnagar, Manipal, Karnataka, India 576104
Udupi
KARNATAKA |
9739398302
melwinmaben@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC-KH Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women diagnosed with GDM according to IADPSG criteria. |
|
| ExclusionCriteria |
| Details |
Pre-existing diabetes mellitus (Type 1 or Type 2)
Medical conditions (hypertension, renal disease, thyroid disorders, epilepsy)
Chronic or Acute Infections
Use of medications known to affect glucose metabolism, like Insulin, Anti-diabetic medications, and hypolipidemic medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Differences in body fat indices: Fat weight, Body fat Percentage, Fat Mass Index, Fat Free mass index, Carnitine Palmitoyl Transferase 1 activity, and inflammatory marker levels: Tumour Necrosis Factor alpha, Interleukin 6 between Insulin Resistant GDM and healthy pregnant controls |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictive association of Fat Mass Index, Carnitine Palmitoyltransferase 1 activity, & inflammatory markers Tumor Necrosis Factor-alpha & Interleukin-6 with composite adverse pregnancy defined as the occurrence of any one or more of the following: macrosomia, caesarean delivery, neonatal hypoglycaemia, or Neonatal Intensive Care Unit admission. |
At the time of delivery of baby |
| To correlate Body Fat Indices Fat Weight, Body Fat Percentage, Fat Mass Index, Fat Free Mass Index, Carnitine Palmitoyltransferase 1 activity, & inflammatory markers Tumor Necrosis Factor alpha, Interleukin 6 with Homeostasis Model Assessment of Insulin Resistance scores |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The pregnant women attending the antenatal clinic will be screened using the inclusion and exclusion criteria and included into the study Eligible participants will be provided with detailed information about the study including its purpose procedures potential risks and benefits and their rights as research participants Informed consent will be obtained from each participant prior to their enrollment in the study Participants will be given ample opportunity to ask questions and clarify any concerns before providing consent The routine investigations performed as standard of care during the Antenatal Visit include Hemoglobin Random Blood Sugar Fasting Blood Sugar Post Prandial Blood Sugar Glycosylated Hemoglobin The lab investigation reports of the tests will be collected by the Principal Investigator The Ultrasound scan parameters done as part of routine care will also be recorded After the routine investigation the demographic details of the pregnant woman will be collected using the Case Report Form
OGTT is done from 12 to 28 weeks
GDM will be diagnosed in line with the following International Association of Diabetes in Pregnancy Study Group standards No history of Diabetes Mellitus before pregnancy but the 75g OGTT fasting plasma glucose level of 92 mgdL 1h postprandial plasma glucose level of 180 mgdL or 2h postprandial plasma glucose of 153 mgdL will be considered as GDM If the OGTT is positive Homeostasis Model Assessment of Insulin Resistance HOMAIR will be calculated based on the glucose and insulin values HOMA IR will be calculated by log Fasting Glucose in mgdl x Fasting Insulin in micro IU per ml divided by 405 If the HOMA is 2 the patients will be included in the Insulin Resistance Gestational Diabetes Mellitus group The investigations for the purpose of this study include CPT1 Assay Insulin Assay for HOMAI R inflammatory markers TNF alpha and Interleukin 6 and antioxidants SOD GSH and MDA An additional 4ml Blood sample will be collected after the diagnosis of GDM for these investigations in the study Apart from these tests the remaining blood which is leftover after performing these tests will be stored for future metabolomic studies using the same sample
Blood is collected in Vacutainers Red insulin CPT1 Grey Fasting glucose The samples will be transported to the lab within 60 minutes centrifuged and aliquoted to tubes and stored at 80C The following parameters will be analyzed CPT1 insulin and fasting glucose After thawing preparation of the sample will be done based on the SOP Appropriate data cleaning and analysis will be done SOD GSH and MDA will be done on the thawed samples according to the SOP CPT 1 will be assayed using sandwich ELISA on 96 well plates in the Department of Biochemistry Insulin will be assayed using sandwich ELISA on 96 well plates in the Department of Biochemistry The InBody test a bioelectrical impedance analysis BIA method measures body composition by sending a lowlevel electrical current through the body to determine the resistance of different tissues The procedure typically involves standing on the device with electrodes placing thumbs on handles with electrodes and maintaining a specific posture while the test is conducted InBody devices use segmental BIA which measures the impedance of different body segments Body fat composition will be done for the following parameters BMI Body Fat Mass Percentage Body Fat Fat Free Mass Skeletal Muscle Mass Followup will be conducted to collect data on fetal weight type of delivery and occurrence of preterm labor These details will primarily be obtained from hospital records at the time of delivery In cases of loss to followup or incomplete records information will be collected through telephonic contact with the patient |