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

This study is currently recruiting participants.
Verified October 2016 by Mount Sinai Hospital, Canada
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832181
First Posted: April 15, 2013
Last Update Posted: October 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Sunnybrook Research Institute
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
April 8, 2013
April 15, 2013
October 19, 2016
April 2013
March 2018   (Final data collection date for primary outcome measure)
Adiposity in the offspring [ Time Frame: 24 months ]
Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).
Same as current
Complete list of historical versions of study NCT01832181 on ClinicalTrials.gov Archive Site
  • Sum of skinfolds in the offspring [ Time Frame: 6, 12 and 24 months ]
    Triceps, subscapular, suprailiac and biceps.
  • Central to peripheral adiposity in the offspring [ Time Frame: 6, 12 and 24 months ]
    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 ]
    Weight and length.
  • Overweight and obesity in the offspring [ Time Frame: 3, 6, 12, 18 and 24 months ]
    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 ]
    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 ]
    Adiponectin and leptin.
Same as current
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MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)
Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Offspring of women with type 2 diabetes who participated in the MiTy trial during pregnancy.
Type 2 Diabetes
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  • Metformin
  • Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
March 2018
March 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact: Ainy Zahid 416-480-6100 ext 87546 MiTyKids@sunnybrook.ca
Contact: Trinh Hoac 416-480-6100 ext 87535 MiTyKids@sunnybrook.ca
Canada
 
 
NCT01832181
10-0129-A
Not Provided
Not Provided
Not Provided
Mount Sinai Hospital, Canada
Mount Sinai Hospital, Canada
  • Sunnybrook Research Institute
  • Canadian Institutes of Health Research (CIHR)
Principal Investigator: Denice Feig, MD Mount Sinai Hospital, Toronto, Ontario, Canada
Mount Sinai Hospital, Canada
October 2016