Type 2 DiabetesNCT01832181
MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)
An observational study of Type 2 Diabetes, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 287 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to May 2021
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Offspring of women with type 2 diabetes who participated in the MiTy trial during pregnancy.
Who may be able to join
- Offspring of women with type 2 diabetes who participated (or are participating) in the MiTy trial.
Who cannot join
- Offspring with major congenital anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, MiTy, Metformin in Women, Type 2 Diabetes Pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
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 |
|---|---|---|
| Metformin | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adiposity in the offspring
Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).
Measured: 24 months
Secondary outcomes (6)
Sum of skinfolds in the offspring
Triceps, subscapular, suprailiac and biceps.
Measured: 6, 12 and 24 months
Central to peripheral adiposity in the offspring
Suprailiac to triceps skinfold ratio.
Measured: 6, 12 and 24 months
Weight gain, BMI and weight-for-length percentile change over time in critical early periods and overall in the offspring.
Weight and length.
Measured: 3, 6, 12, 18 and 24 months
Overweight and obesity in the offspring
BMI >85th percentile (overweight) and BMI >97th percentile (obesity) for age and gender from World Health Organization (WHO) growth charts.
Measured: 3, 6, 12, 18 and 24 months
Insulin resistance in the offspring
Fasting insulin, fasting insulin-to-glucose ratio, and the Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR).
Measured: 24 months
adipocytokine profile in the offspring
Adiponectin and leptin.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Denice Feig, MD, Principal investigator, Mount Sinai Hospital, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832181
- Sponsor's protocol ID
- 10-0129-A
- Status last verified
- Nov 2021
- First submitted
- 8 Apr 2013
- Last updated
- 30 Nov 2021
- Results posted
- No
Publications
Feig DS, Sanchez JJ, Murphy KE, Asztalos E, Zinman B, Simmons D, Haqq AM, Fantus IG, Lipscombe L, Armson A, Barrett J, Donovan L, Karanicolas P, Tobin S, Mangoff K, Klein G, Jiang Y, Tomlinson G, Hamilton J; MiTy Kids Collaborative Group. Outcomes in children of women with type 2 diabetes exposed to metformin versus placebo during pregnancy (MiTy Kids): a 24-month follow-up of the MiTy randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Mar;11(3):191-202. doi: 10.1016/S2213-8587(23)00004-9. Epub 2023 Feb 3.
PubMed 36746160
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)
- ClinicalTrials.gov ID
- NCT01832181
- Acronym / sponsor ID
- 10-0129-A
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, MiTy, Metformin in Women, Type 2 Diabetes Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute, Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2013
- Primary completion
- Apr 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 15 Apr 2013 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Offspring of women with type 2 diabetes who participated in the MiTy trial during pregnancy.
Key inclusion criteria (1 listed)
- Offspring of women with type 2 diabetes who participated (or are participating) in the MiTy trial.
Key exclusion criteria (1 listed)
- Offspring with major congenital anomalies.
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
Adiposity in the offspring
Time frame: 24 months
Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).
6 secondary outcomes
Sum of skinfolds in the offspring
Time frame: 6, 12 and 24 months
Central to peripheral adiposity in the offspring
Time frame: 6, 12 and 24 months
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
Overweight and obesity in the offspring
Time frame: 3, 6, 12, 18 and 24 months
Insulin resistance in the offspring
Time frame: 24 months
adipocytokine profile in the offspring
Time frame: 24 months
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 30 Nov 2021.
- Derived from this study: PubMed 36746160Feig DS, Sanchez JJ, Murphy KE, Asztalos E, Zinman B, Simmons D, Haqq AM, Fantus IG, Lipscombe L, Armson A, Barrett J, Donovan L, Karanicolas P, Tobin S, Mangoff K, Klein G, Jiang Y, Tomlinson G, Hamilton J; MiTy Kids Collaborative Group. Outcomes in children of women with type 2 diabetes exposed to metformin versus placebo during pregnancy (MiTy Kids): a 24-month follow-up of the MiTy randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Mar;11(3):191-202. doi: 10.1016/S2213-8587(23)00004-9. Epub 2023 Feb 3.
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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.
Denice Feig, MD principal investigator
Mount Sinai Hospital, Toronto, Ontario, Canada
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 Type 2 Diabetes, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 1 inclusion and 1 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 30 Nov 2021. 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 Canada. 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?
Adiposity in the offspring (time frame: 24 months). 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 NCT01832181, which also lists 1 linked publication.
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 30 Nov 2021.