Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby

NCT03008824 | Unknown

• 1 other identifier: MR/J000094/1
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

There is a rapidly escalating epidemic of obesity and type 2 diabetes across the world, with the fastest rise occurring in low- and middle-income countries. India not only has one of the highest rates in the world, but the disease starts at a younger age and lower levels of body weight than in UK white caucasians. Among city-dwelling Indians, approximately 8% of people aged 30-40 years already have diabetes. This is creating a heavy burden of disease and disability, and an intolerable economic burden through medical costs and lost earnings. Until now, efforts to prevent diabetes have mainly focussed on modifying the diet, lifestyle and activity of at-risk adults (for example those who are overweight, have a family history of diabetes or already have high blood sugar). However, recent research has indicated that factors acting in early life (during development in the womb) place an individual at risk of later diabetes. These include maternal malnutrition and low birthweight, and diabetes in the mother during pregnancy. Our research has shown that Indian mothers often have low vitamin B12 levels, which in turn causes high blood levels of a harmful metabolite (homocysteine). We have shown that these mothers get more diabetes in pregnancy. Their children are more likely to born with a low birth weight, and develop more body fat and higher plasma insulin levels during childhood, which are signs of higher diabetes risk in later life. The risk is increased further if the mother has normal or high status for another B vitamin, folate. Thus, we have shown, for the first time a link between a specific nutritional deficiency in the mother and diabetes risk in the next generation. One possible mechanism for the effect of maternal nutrition on risk of diabetes in her children is through epigenetic effects, whereby the nutritional environment during early development affects the switches that control gene expression. Since these switches are passed on via either parent, we think it is possible that paternal vitamin B12 status could also be important.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Differences in B12 levels between GDM and Controls

  5 Years

Secondary Outcomes (7)

• Differences in B12 levels in South Asians and White Caucasians

  5 years

• Differences between offspring birth weight between GDM and controls

  5 years

• Differences between offspring adiposity between GDM and controls

  5 years

• Differences between offspring birth weight between South Asians and White Caucasians

  5 years

• Differences between offspring adiposity between South Asians and White Caucasians

  5 years

Other Outcomes (7)

• Psychological impact of the diagnosis of GDM in each ethnicity

  5 years

• Role of sedentary behavior on incident GDM

  5 years

• Role of physical activity on incident GDM

  5 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women between 18-75 years of age who satisfy NICE criteria for GDM screening

You may qualify if:

• Pregnant women \<16 years of age
• High risk for GDM (at least 1 of the risk factors) - BMI \>30
• Previous GDM
• First degree relatives with GDM
• Previous unexplained still birth
• Previous baby \>4.5kg
• PCOS
• Ethnic minority groups
• Age \>35years

You may not qualify if:

• Pregestational Type 1 or Type 2 Diabetes
• Diagnosis of B12 or folate deficiency in the current pregnancy
• Previous pregnancies with NTDs
• Diagnosis of severe aneamia (\<10g/dL)
• Vitamin B12 injections in the previous 6 months

Sponsors & Collaborators

• University of Warwick: lead
• George Eliot Hospital NHS Trust: collaborator

Study Sites (1)

University of Warwick

Coventry, Coventry, CV47AL, United Kingdom

RECRUITING

Related Publications (1)

• Saravanan P, Sukumar N, Adaikalakoteswari A, Goljan I, Venkataraman H, Gopinath A, Bagias C, Yajnik CS, Stallard N, Ghebremichael-Weldeselassie Y, Fall CHD. Association of maternal vitamin B12 and folate levels in early pregnancy with gestational diabetes: a prospective UK cohort study (PRiDE study). Diabetologia. 2021 Oct;64(10):2170-2182. doi: 10.1007/s00125-021-05510-7. Epub 2021 Jul 22.

  PMID: 34296321 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and whole blood for isolating DNA

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ponnusamy Saravanan, FRCP PhD

  University of Warwick

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ponnusamy Saravanan, FRCP PhD

CONTACT

00442476865329; p.saravanan@warwick.ac.uk

Amitha Gopinath, MBA

CONTACT

00442476153592; amitha.gopinath@geh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 4, 2017
• Study Start: September 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: January 4, 2017

Record last verified: 2016-12

Locations

GB (1)