MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mount Sinai Hospital, Canada
Sponsor:
Collaborators:
Sunnybrook Research Institute
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01832181
First received: April 8, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

The prevalence of diabetes in pregnancy is rising in all maternal age groups. There is increasing evidence that in-utero exposure to maternal diabetes is associated with an increased risk of obesity and type 2 diabetes in children and adults. There is an urgent need to reduce these increasing rates of obesity and diabetes in subsequent generations.

The MiTy Trial (Metformin in Women with Type 2 Diabetes in Pregnancy Trial) is a CIHR-funded multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample size n=500). The MiTy Trial is looking to determine the effect of the addition of metformin to a standard regimen of insulin in women with diabetes, on perinatal morbidity and mortality.

The MiTy Kids Trial is a follow-up to the MiTy Trial which will determine whether treatment with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2 years of age.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Adiposity in the offspring [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).


Secondary Outcome Measures:
  • Sum of skinfolds in the offspring [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Triceps, subscapular, suprailiac and biceps.

  • Central to peripheral adiposity in the offspring [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Suprailiac to triceps skinfold ratio.

  • Weight gain, BMI and weight-for-length percentile change over time in critical early periods and overall in the offspring. [ Time Frame: 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Weight and length.

  • Overweight and obesity in the offspring [ Time Frame: 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    BMI >85th percentile (overweight) and BMI >97th percentile (obesity) for age and gender from World Health Organization (WHO) growth charts.

  • Insulin resistance in the offspring [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Fasting insulin, fasting insulin-to-glucose ratio, and the Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR).

  • adipocytokine profile in the offspring [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Adiponectin and leptin.


Estimated Enrollment: 450
Study Start Date: April 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Metformin
Control

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Offspring of women with type 2 diabetes who participated in the MiTy trial during pregnancy.

Criteria

Inclusion Criteria:

  • Offspring of women with type 2 diabetes who participated (or are participating) in the MiTy trial.

Exclusion Criteria:

  • Offspring with major congenital anomalies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832181

Contacts
Contact: Adriana Rodriguez-Valentini 416-480-5630 MiTyKids@sunnybrook.ca
Contact: Jessica Stortz 416-480-6100 ext 87546 MiTyKids@sunnybrook.ca

Locations
Canada, Ontario
Dr. Denice Feig Recruiting
Toronto, Ontario, Canada
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Sunnybrook Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Denice Feig, MD Mount Sinai Hospital, Toronto, Ontario, Canada
  More Information

No publications provided

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01832181     History of Changes
Other Study ID Numbers: 10-0129-A
Study First Received: April 8, 2013
Last Updated: March 20, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Mount Sinai Hospital, Canada:
Diabetes
MiTy
Metformin in Women
Type 2 Diabetes Pregnancy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Pregnancy in Diabetics
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014