Gestational DiabetesInDiaGDMNCT03388723
Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
An observational study of Gestational Diabetes, run by Kem Hospital, Pune, India at 1 site in India.
Trial summary
India is one of the diabetes capitals in the world. Indians are susceptible to develop diabetes at a younger age and at a lower BMI compared to Europeans. Current prevention strategies focus on reducing risk in those with the established disease or risk factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 1,178 participants
- Where
- 1 siteIndia
- Study dates
- 2 Sep 2014to 30 Nov 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Arm 1 and Arm 2: GDM women (diagnosed on OGTT) and women with normal glucose tolerance on OGTT and their offspring. Arm 3: Offspring of diabetic mothers and non diabetic mothers
Who may be able to join
- Arm 1 and 2:
- GDM or NGT on 75g OGTT (IADPSG Criteria).
- Willing to participate and sign consent
- Planned delivery at study site
- Age > 18 years
- Singleton pregnancy.
- Arm 3:
- 1. Offspring of diabetic mothers and non diabetic mothers ( >2 years of age).
Who cannot join
- Arm 1 and 2:
- Severe medical/ surgical illness detrimental to pregnancy or delivery (Severe liver, renal, cardiovascular, pulmonary, hematologic, endocrine disorder or long term steroid use for any reason)
- K/C/O Diabetes (Type 1 or Type 2 or any other type)
- Severe anemia (Hemoglobin< 9 gm% in first trimester and < 8 gm% in second or third trimester)
- IVF pregnancy.
- Arm 3: None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Epigenetics in the Vicious Cycle of Diabetes and Pregnancy (VICYDIP)
India is one of the diabetes capitals in the world. Indians are susceptible to develop diabetes at a younger age and at a lower BMI compared to Europeans. Current prevention strategies focus on reducing risk in those with the established disease or risk factors. The Developmental Origins of Health and Disease (DOHaD) hypothesis suggests that chronic non-communicable diseases (NCDs) are programmed by disturbances in maternal and fetal undernutrition. This offers an alternative primordial prevention strategy to reduce NCDs in future generations by improving health and nutrition of young women. Previous work in the Diabetes Unit, KEM Hospital, Pune has described the role of maternal micronutrients affecting 1-Carbon metabolism in the fetal programming of diabesity. In this application, the investigators offer to study other pathways of fetal programming i.e. maternal hyperglycemia and gestational diabetes mellitus (GDM) using an 'OMICs' approach. It is believed that epigenetic changes may be the main driver of programming. The investigators hypothesize that offspring of diabetic mothers will have different epigenetic signatures in cord blood and placenta compared to offspring of non-diabetic mothers. The investigators propose to study the effect of gestational hyperglycemia on newborn epigenetic signatures using the most appropriate technologies available and associate them with the underlying genotype. This will be performed on cord blood of 150 offspring of women with GDM and compared with a similar number of offspring of non-diabetic mothers recruited at Pune. The differentially methylated regions (DMRs) identified will then be validated by pyrosequencing in ~300 stored GDM cord blood samples in Pune. The investigators from Pune will also validate these markers in 200 newly recruited offspring of GDM and 200 controls from a different cohort in Punjab which has a different diet and lifestyle. The DMRs will also be validated in placental samples from both Pune and Punjab. The investigators will further test the stability of these markers and their associations with phenotype in a follow-up study of offspring of GDM mothers in upto 500 individuals. The investigators will compare the findings with the DNBC-GDM cohort in Denmark, allowing for differences in age, genetic make up, nutritional status and lifestyle. This study will help understand contribution of maternal diabetes to the current epidemic of diabesity and its molecular basis.
Read the detailed description
The DOHaD paradigm proposes that early life nutrition and growth influence health and disease risk across the life-course. Intrauterine period is the most crucial period in these events, and contributes to fetal programming. Fetal undernutrition as well as over-nutrition (maternal obesity and diabetes) increase risk of diabetes in the offspring. Current thinking is that fetal programming is an 'epigenetic' phenomenon and the most prominent mechanism may be methylation of DNA and histones that regulate gene expression in key pathways. The investigators have previously highlighted a role for maternal micronutrients in fetal programming of adiposity, insulin resistance, and prediabetes (nutrient mediated teratogenesis). Now, the investigators propose to study the impact of maternal hyperglycemia during pregnancy on the future risk of diabesity in the offspring (fuel mediated teratogenesis). This programme, first of its kind in India, will undertake 'OMICs' measurements (DNA methylation and targeted metabolomics) on cord blood samples of children born to women with gestation diabetes mellitus (GDM), in studies in Pune, Western India (Arm-1) and Punjab, North India (Arm-2). Markers identified in the discovery phase will be investigated for validity and stability in blood, cord blood and placenta samples from children born to GDM mothers in the older cohorts in Pune and Punjab. Danish investigators will perform complimentary measurements in the Danish National Birth Cohort which will allow comparison of epigenetic markers in these two populations with widely different prevalence of GDM, and ethnic and nutritional factors. Special attention will be given to role of nutritional and lifestyle factors of mothers which influence the programming of fetal epigenome during pregnancy. The biobank of maternal, cord and offspring samples will be available in future to test newer hypotheses. This study will benefit from technology transfer across two countries. The findings will add substantially to the evidence base of intergenerational transmission of diabetes in a diabetic pregnancy, and will inform policy-makers to help curb the escalating epidemic of diabetes in India.
Hypotheses
- The molecular mechanisms underlying the associations between gestational diabetes in the mother and diabesity in the offspring may involve permanent changes of DNA methylations in various tissues including blood cells obtained at birth and/or during childhood defining different trajectories.
- Epigenetic fingerprints linking GDM with risk of T2D among the offspring may or may not be influenced by tissue of origin, diet, life-style and ethnicity of population.
- Epigenetic changes in blood cells obtained at birth and/or during childhood associated with GDM in pregnancy may be used as bio-markers to predict later development of T2D in the offspring
- The risk of developing diabetes among offspring of GDM women may be influenced by maternal factors operating during pregnancy including degree of hyperglycemia, obesity, dietary factors including composition of macro- and micronutrients, and/or by the level of physical activity of the mother.
- Conditions
- Gestational Diabetes
- Keywords
- Epigenetics, Cardiometabolic risk factors
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Discovery phase | Approximately 150 women with Gestational Diabetes Mellitus (GDM) and 150 controls, and their offspring will be recruited in Pune (from KEM Hospital and Vadu). The objective will be: 1. Identification of epigenetic signatures 2. Measurements of B vitamins and 1-C metabolites in mothers' blood and cord blood 3. Glucose, insulin and lipids in mothers during pregnancy 4. Anthropometry and blood pressure | |
| Arm 2: Validation phase | Approximately 200 women with Gestational Diabetes Mellitus (GDM) and 200 controls, and their offspring will be recruited in Punjab, and 150 stored cord blood samples of GDM offspring in Pune will be investigated to validate the epigenetic signatures discovered in Arm 1. | |
| Arm 3: Stability phase | Approximately 500 offspring of women with Gestational Diabetes Mellitus (GDM) from Pune (~ half below 10 years and the rest over 10 years) will be investigated to study: 1. Stability of epigenetic signatures in offspring through childhood and adolescence 2. Relation of these signatures with phenotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic signatures in the cord blood of the offspring of GDM mothers.
The Illumina Infinium Human Methylation 450K array will be used for DNA methylation study. It generates a quantitative measurement of DNA methylation for >480,000 CpG sites spanning all annotated genes and other functional motifs. Markers influencing risk of diabetes and obesity will be of special interest. Approximately 150 GDM and 150 normal glucose tolerant pregnancies will contribute the samples.
Measured: Upto 3 years from the start of the study
Secondary outcomes (5)
Association of the genotype with differentially methylated DNA regions.
The Human OmniExpress Exome BeadChip will be used for generating genome wide data. It provides a backbone of >700,000 genome-wide markers (SNPs >5% minor allele frequencies) and 240,000 coding SNPs of all frequencies. This will allow to identify the variants that act as meQTLS.
Measured: Upto 3.5 years from the start of the study
Validation of the epigenetic signatures generated in Primary Outcome 1.
Quantitative profile of DNA methylation at specific CpG sites will be done using Bisulfite Pyrosequencing [Sequenom EpiTYPER], in cord blood samples obtained in Pune and in Ludhiana.
Measured: Upto 3.5 years from the start of the study
Stability of epigenetic signatures discovered in the cord blood in offspring GDM mothers from childhood through adolescence.
The cord blood differential epigenetic signatures will be investigated in the blood sample of the offspring of GDM mothers during childhood and adolescence. These children were born to GDM patients attending the diabetes clinic at KEM hospital, Pune over last 2 decades.
Measured: Upto 4 years from the start of the study
Association between epigenetic signatures and offspring phenotype at birth , and in childhood and adolescence.
Following phenotype measures will be tested :
- Weight (Kg)
- Height (cm)
- BMI (Kg/m^2)
- Waist circumference (cm)
- Hip circumference (cm)
- Skinfolds (mm)
- DXA [ body composition measures: fat, lean and bone]
- Plasma Glucose concentration (mg/dl) in the cord blood and during an OGTT in childhood and adolescence.
- Plasma Insulin (mU/L) in the cord blood and during an OGTT in childhood and adolescence
- Glucose and insulin indices (HOMA measures) in 8, 9.
- Blood lipids (Cholesterol, HDL, LDL and Triglycerides) in the cord blood and during an OGTT in childhood and adolescence.
Measured: Upto 4 years from the start of the study
Qualitative and quantitative comparison of epigenetic signatures in the offspring of GDM mothers [Indian and Danish cohort].
Epigenetic signatures from Indian and Denmark cohorts will be compared, taking into account differences in genetic background, nutrition and lifestyle.
Comparison will focus on the direction and strength of associations, and the metabolic pathways implicated in the above analysis.
Measured: Upto 4.5 years from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start2 Sep 2014
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kem Hospital, Pune, India
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Cellular and Molecular Biology, Hyderabad, India
- Responsible party
- Principal investigator, Dr. Chittaranjan S Yajnik, Kem Hospital, Pune, India
- Investigators
- Chittaranjan Chittaranjan, MD FRCP, Principal investigator, Director, Diabetes Unit, KEM Hospital Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388723
- Sponsor's protocol ID
- KEMHRC ID No. 1404
- Acronym
- InDiaGDM
- Status last verified
- Mar 2019
- First submitted
- 26 Oct 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dabelea D, Pettitt DJ. Intrauterine diabetic environment confers risks for type 2 diabetes mellitus and obesity in the offspring, in addition to genetic susceptibility. J Pediatr Endocrinol Metab. 2001 Sep-Oct;14(8):1085-91. doi: 10.1515/jpem-2001-0803.
PubMed 11592564Petitt DJ, Bennett PH, Knowler WC, Baird HR, Aleck KA. Gestational diabetes mellitus and impaired glucose tolerance during pregnancy. Long-term effects on obesity and glucose tolerance in the offspring. Diabetes. 1985 Jun;34 Suppl 2:119-22. doi: 10.2337/diab.34.2.s119.
PubMed 3996763Gluckman PD, Hanson MA, Cooper C, Thornburg KL. Effect of in utero and early-life conditions on adult health and disease. N Engl J Med. 2008 Jul 3;359(1):61-73. doi: 10.1056/NEJMra0708473. No abstract available.
PubMed 18596274Wu L, Cui L, Tam WH, Ma RC, Wang CC. Genetic variants associated with gestational diabetes mellitus: a meta-analysis and subgroup analysis. Sci Rep. 2016 Jul 29;6:30539. doi: 10.1038/srep30539.
PubMed 27468700Ma RC, Tutino GE, Lillycrop KA, Hanson MA, Tam WH. Maternal diabetes, gestational diabetes and the role of epigenetics in their long term effects on offspring. Prog Biophys Mol Biol. 2015 Jul;118(1-2):55-68. doi: 10.1016/j.pbiomolbio.2015.02.010. Epub 2015 Mar 16.
PubMed 25792090Yajnik CS. Fetal programming of diabetes: still so much to learn! Diabetes Care. 2010 May;33(5):1146-8. doi: 10.2337/dc10-0407. No abstract available.
PubMed 20427687Kale SD, Yajnik CS, Kulkarni SR, Meenakumari K, Joglekar AA, Khorsand N, Ladkat RS, Ramdas LV, Lubree HG. High risk of diabetes and metabolic syndrome in Indian women with gestational diabetes mellitus. Diabet Med. 2004 Nov;21(11):1257-8. doi: 10.1111/j.1464-5491.2004.01337.x. No abstract available.
PubMed 15498096Kale SD, Kulkarni SR, Lubree HG, Meenakumari K, Deshpande VU, Rege SS, Deshpande J, Coyaji KJ, Yajnik CS. Characteristics of gestational diabetic mothers and their babies in an Indian diabetes clinic. J Assoc Physicians India. 2005 Oct;53:857-63.
PubMed 16459528Yajnik CS. Transmission of obesity-adiposity and related disorders from the mother to the baby. Ann Nutr Metab. 2014;64 Suppl 1:8-17. doi: 10.1159/000362608. Epub 2014 Jul 23.
PubMed 25059801
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Epigenetics in the Vicious Cycle of Diabetes and Pregnancy (VICYDIP)
- ClinicalTrials.gov ID
- NCT03388723
- Acronym / sponsor ID
- InDiaGDM / KEMHRC ID No. 1404
- Conditions
- Gestational Diabetes
- Keywords
- Epigenetics, Cardiometabolic risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,178 participants (actual)
- Lead sponsor
- Kem Hospital, Pune, IndiaUniversity, hospital or other
- Collaborators
- Centre for Cellular and Molecular Biology, Hyderabad, India
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
India is one of the diabetes capitals in the world. Indians are susceptible to develop diabetes at a younger age and at a lower BMI compared to Europeans. Current prevention strategies focus on reducing risk in those with the established disease or risk factors. The Developmental Origins of Health and Disease (DOHaD) hypothesis suggests that chronic non-communicable diseases (NCDs) are programmed by disturbances in maternal and fetal undernutrition. This offers an alternative primordial prevention strategy to reduce NCDs in future generations by improving health and nutrition of young women. Previous work in the Diabetes Unit, KEM Hospital, Pune has described the role of maternal micronutrients affecting 1-Carbon metabolism in the fetal programming of diabesity. In this application, the investigators offer to study other pathways of fetal programming i.e. maternal hyperglycemia and gestational diabetes mellitus (GDM) using an 'OMICs' approach. It is believed that epigenetic changes may be the main driver of programming. The investigators hypothesize that offspring of diabetic mothers will have different epigenetic signatures in cord blood and placenta compared to offspring of non-diabetic mothers. The investigators propose to study the effect of gestational hyperglycemia on newborn epigenetic signatures using the most appropriate technologies available and associate them with the underlying genotype. This will be performed on cord blood of 150 offspring of women with GDM and compared with a similar number of offspring of non-diabetic mothers recruited at Pune. The differentially methylated regions (DMRs) identified will then be validated by pyrosequencing in ~300 stored GDM cord blood samples in Pune. The investigators from Pune will also validate these markers in 200 newly recruited offspring of GDM and 200 controls from a different cohort in Punjab which has a different diet and lifestyle. The DMRs will also be validated in placental samples from both Pune and Punjab. The investigators will further test the stability of these markers and their associations with phenotype in a follow-up study of offspring of GDM mothers in upto 500 individuals. The investigators will compare the findings with the DNBC-GDM cohort in Denmark, allowing for differences in age, genetic make up, nutritional status and lifestyle. This study will help understand contribution of maternal diabetes to the current epidemic of diabesity and its molecular basis.
Detailed description
The DOHaD paradigm proposes that early life nutrition and growth influence health and disease risk across the life-course. Intrauterine period is the most crucial period in these events, and contributes to fetal programming. Fetal undernutrition as well as over-nutrition (maternal obesity and diabetes) increase risk of diabetes in the offspring. Current thinking is that fetal programming is an 'epigenetic' phenomenon and the most prominent mechanism may be methylation of DNA and histones that regulate gene expression in key pathways. The investigators have previously highlighted a role for maternal micronutrients in fetal programming of adiposity, insulin resistance, and prediabetes (nutrient mediated teratogenesis). Now, the investigators propose to study the impact of maternal hyperglycemia during pregnancy on the future risk of diabesity in the offspring (fuel mediated teratogenesis). This programme, first of its kind in India, will undertake 'OMICs' measurements (DNA methylation and targeted metabolomics) on cord blood samples of children born to women with gestation diabetes mellitus (GDM), in studies in Pune, Western India (Arm-1) and Punjab, North India (Arm-2). Markers identified in the discovery phase will be investigated for validity and stability in blood, cord blood and placenta samples from children born to GDM mothers in the older cohorts in Pune and Punjab. Danish investigators will perform complimentary measurements in the Danish National Birth Cohort which will allow comparison of epigenetic markers in these two populations with widely different prevalence of GDM, and ethnic and nutritional factors. Special attention will be given to role of nutritional and lifestyle factors of mothers which influence the programming of fetal epigenome during pregnancy. The biobank of maternal, cord and offspring samples will be available in future to test newer hypotheses. This study will benefit from technology transfer across two countries. The findings will add substantially to the evidence base of intergenerational transmission of diabetes in a diabetic pregnancy, and will inform policy-makers to help curb the escalating epidemic of diabetes in India.
Hypotheses
- The molecular mechanisms underlying the associations between gestational diabetes in the mother and diabesity in the offspring may involve permanent changes of DNA methylations in various tissues including blood cells obtained at birth and/or during childhood defining different trajectories.
- Epigenetic fingerprints linking GDM with risk of T2D among the offspring may or may not be influenced by tissue of origin, diet, life-style and ethnicity of population.
- Epigenetic changes in blood cells obtained at birth and/or during childhood associated with GDM in pregnancy may be used as bio-markers to predict later development of T2D in the offspring
- The risk of developing diabetes among offspring of GDM women may be influenced by maternal factors operating during pregnancy including degree of hyperglycemia, obesity, dietary factors including composition of macro- and micronutrients, and/or by the level of physical activity of the mother.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Discovery phase | – | –Approximately 150 women with Gestational Diabetes Mellitus (GDM) and 150 controls, and their offspring will be recruited in Pune (from KEM Hospital and Vadu). The objective will be: 1. Identification of epigenetic signatures 2. Measurements of B vitamins and 1-C metabolites in mothers' blood and cord blood 3. Glucose, insulin and lipids in mothers during pregnancy 4. Anthropometry and blood pressure |
| Arm 2: Validation phase | – | –Approximately 200 women with Gestational Diabetes Mellitus (GDM) and 200 controls, and their offspring will be recruited in Punjab, and 150 stored cord blood samples of GDM offspring in Pune will be investigated to validate the epigenetic signatures discovered in Arm 1. |
| Arm 3: Stability phase | – | –Approximately 500 offspring of women with Gestational Diabetes Mellitus (GDM) from Pune (~ half below 10 years and the rest over 10 years) will be investigated to study: 1. Stability of epigenetic signatures in offspring through childhood and adolescence 2. Relation of these signatures with phenotype |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Arm 1 and Arm 2: GDM women (diagnosed on OGTT) and women with normal glucose tolerance on OGTT and their offspring. Arm 3: Offspring of diabetic mothers and non diabetic mothers
Key inclusion criteria (8 listed)
- GDM or NGT on 75g OGTT (IADPSG Criteria).
- Willing to participate and sign consent
- Planned delivery at study site
- Age > 18 years
- Singleton pregnancy.
Key exclusion criteria (6 listed)
- Severe medical/ surgical illness detrimental to pregnancy or delivery (Severe liver, renal, cardiovascular, pulmonary, hematologic, endocrine disorder or long term steroid use for any reason)
- K/C/O Diabetes (Type 1 or Type 2 or any other type)
- Severe anemia (Hemoglobin< 9 gm% in first trimester and < 8 gm% in second or third trimester)
- IVF pregnancy.
- Arm 3: None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epigenetic signatures in the cord blood of the offspring of GDM mothers.
Time frame: Upto 3 years from the start of the study
The Illumina Infinium Human Methylation 450K array will be used for DNA methylation study. It generates a quantitative measurement of DNA methylation for >480,000 CpG sites spanning all annotated genes and other functional motifs. Markers influencing risk of diabetes and obesity will be of special interest. Approximately 150 GDM and 150 normal glucose tolerant pregnancies will contribute the samples.
5 secondary outcomes
Association of the genotype with differentially methylated DNA regions.
Time frame: Upto 3.5 years from the start of the study
Validation of the epigenetic signatures generated in Primary Outcome 1.
Time frame: Upto 3.5 years from the start of the study
Stability of epigenetic signatures discovered in the cord blood in offspring GDM mothers from childhood through adolescence.
Time frame: Upto 4 years from the start of the study
Association between epigenetic signatures and offspring phenotype at birth , and in childhood and adolescence.
Time frame: Upto 4 years from the start of the study
Qualitative and quantitative comparison of epigenetic signatures in the offspring of GDM mothers [Indian and Danish cohort].
Time frame: Upto 4.5 years from the start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Background: PubMed 11592564Dabelea D, Pettitt DJ. Intrauterine diabetic environment confers risks for type 2 diabetes mellitus and obesity in the offspring, in addition to genetic susceptibility. J Pediatr Endocrinol Metab. 2001 Sep-Oct;14(8):1085-91. doi: 10.1515/jpem-2001-0803.
- Background: PubMed 3996763Petitt DJ, Bennett PH, Knowler WC, Baird HR, Aleck KA. Gestational diabetes mellitus and impaired glucose tolerance during pregnancy. Long-term effects on obesity and glucose tolerance in the offspring. Diabetes. 1985 Jun;34 Suppl 2:119-22. doi: 10.2337/diab.34.2.s119.
- Background: PubMed 18596274Gluckman PD, Hanson MA, Cooper C, Thornburg KL. Effect of in utero and early-life conditions on adult health and disease. N Engl J Med. 2008 Jul 3;359(1):61-73. doi: 10.1056/NEJMra0708473. No abstract available.
- Background: PubMed 27468700Wu L, Cui L, Tam WH, Ma RC, Wang CC. Genetic variants associated with gestational diabetes mellitus: a meta-analysis and subgroup analysis. Sci Rep. 2016 Jul 29;6:30539. doi: 10.1038/srep30539.
- Background: PubMed 25792090Ma RC, Tutino GE, Lillycrop KA, Hanson MA, Tam WH. Maternal diabetes, gestational diabetes and the role of epigenetics in their long term effects on offspring. Prog Biophys Mol Biol. 2015 Jul;118(1-2):55-68. doi: 10.1016/j.pbiomolbio.2015.02.010. Epub 2015 Mar 16.
- Background: PubMed 20427687Yajnik CS. Fetal programming of diabetes: still so much to learn! Diabetes Care. 2010 May;33(5):1146-8. doi: 10.2337/dc10-0407. No abstract available.
- Background: PubMed 15498096Kale SD, Yajnik CS, Kulkarni SR, Meenakumari K, Joglekar AA, Khorsand N, Ladkat RS, Ramdas LV, Lubree HG. High risk of diabetes and metabolic syndrome in Indian women with gestational diabetes mellitus. Diabet Med. 2004 Nov;21(11):1257-8. doi: 10.1111/j.1464-5491.2004.01337.x. No abstract available.
- Background: PubMed 16459528Kale SD, Kulkarni SR, Lubree HG, Meenakumari K, Deshpande VU, Rege SS, Deshpande J, Coyaji KJ, Yajnik CS. Characteristics of gestational diabetic mothers and their babies in an Indian diabetes clinic. J Assoc Physicians India. 2005 Oct;53:857-63.
- Background: PubMed 25059801Yajnik CS. Transmission of obesity-adiposity and related disorders from the mother to the baby. Ann Nutr Metab. 2014;64 Suppl 1:8-17. doi: 10.1159/000362608. Epub 2014 Jul 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chittaranjan Chittaranjan, MD FRCP principal investigator
Director, Diabetes Unit, KEM Hospital Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Kem Hospital, Pune, India at 1 site in India.
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 8 inclusion and 6 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Epigenetic signatures in the cord blood of the offspring of GDM mothers. (time frame: Upto 3 years from the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388723, which also lists 9 linked publications.
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 1 Apr 2019.