Insulin ResistanceNCT03524469
Studying Infant Nutrition and Blood Sugar
An observational study of Insulin Resistance and Obesity, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to learn about how breast milk from mothers with insulin-resistance may be different. Investigators are specifically studying insulin concentrations in breast milk. Investigators are also studying how insulin in breast milk might affect a baby's intestines and pancreas. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity
- Type of treatment
- Pill or oral medicine
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Dec 2024
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The inclusion criteria were selected to include only healthy infants of uncomplicated pregnancy (with the exception of gestational diabetes) and normal birth weight. The criteria for insulin resistance were strategically defined to capture the insulin-resistant population which represents a large proportion of the population that are at risk for diabetes but have not yet developed the disease. Insulin therapy is an exclusion criteria because it passes through the breast milk and we are unable to distinguish endogenous maternal insulin from exogenous therapeutic insulin in breast milk samples. These criteria will minimize the risks and increase the safety of subjects.
Who may be able to join
- Mothers ≥ 19 years of age
- Mothers intending to Exclusively Breastfeed for at least 5months
- Mothers comfortable with feeding their infants expressed breast milk from a bottle at 2-weeks postpartum
- Trial of labor (no scheduled C-sections)
- Singleton birth
- Healthy Infants
Show all 12Show fewer
- "Normal Weight" will be defined as pre-pregnant BMI between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test.
- "Insulin Resistance" will be defined as meeting any of the following:
- pre-pregnant BMI ≥ 28 and failed the 28 week oral glucose screening test
- pre-pregnant BMI ≥ 28 and diagnosis of either A1 ("diet controlled") or A2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth.
- pre-pregnant BMI ≥ 28 and diagnosed with type 2 diabetes during pregnancy
- pre-pregnant BMI ≥ 30, and unmediated.
Who cannot join
- Scheduled C-sections or emergency C-sections with no labor (natural or induced)
- Maternal insulin therapy after birth
- Significant maternal health concern including type 1 diabetes, renal, kidney, thyroid, or cardiovascular disease, pre-eclampsia, or other disease.
- Delivery before 37 weeks
- Infant birth weight <2500g
- Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns
- Infant supplementation with infant formula (glucose gel or donor milk is acceptable)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center of the University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Studying Infant Nutrition and Glycemia (SING)
The purpose of this study is to learn about how breast milk from mothers with insulin-resistance may be different. Investigators are specifically studying insulin concentrations in breast milk. Investigators are also studying how insulin in breast milk might affect a baby's intestines and pancreas.
- Conditions
- Insulin Resistance, Obesity
- Medical subject headings
- Insulin Resistance, Obesity
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 |
|---|---|---|
| Normal weight | "Normal Weight" will be defined as pre-pregnant BMI between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test. | |
| Insulin resistant | "Insulin Resistance" will be defined as meeting any of the following: * pre-pregnant BMI ≥ 28 and failed the 28 week oral glucose screening test * pre-pregnant BMI ≥ 28 and diagnosis of either A1 ("diet controlled") or A2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth. * pre-pregnant BMI ≥ 28 and diagnosed with type 2 diabetes during pregnancy * pre-pregnant BMI ≥ 30, and unmediated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean infant postprandial C peptide to creatinine ratio
Postprandial urine (60-90 minute) will be tested for C peptide and creatinine and the ratio will be calculated.
Measured: 2 weeks
Secondary outcomes (1)
mean infant insulinogenic index
The insulinogenic index will be measures in infant blood at 0 and 30 minutes post glucose administration. The index is the change in insulin over the change in glucose.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Gerber Foundation
- Responsible party
- Principal investigator, Bridget Young, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524469
- Sponsor's protocol ID
- RSRB71535
- Other IDs
- K01DK115710
- Status last verified
- Dec 2024
- First submitted
- 2 May 2018
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Infant Nutrition and Glycemia (SING)
- ClinicalTrials.gov ID
- NCT03524469
- Acronym / sponsor ID
- RSRB71535
- Conditions
- Insulin Resistance, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Gerber Foundation
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 May 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.
The purpose of this study is to learn about how breast milk from mothers with insulin-resistance may be different. Investigators are specifically studying insulin concentrations in breast milk. Investigators are also studying how insulin in breast milk might affect a baby's intestines and pancreas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | –"Normal Weight" will be defined as pre-pregnant BMI between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test. |
| Insulin resistant | – | –"Insulin Resistance" will be defined as meeting any of the following: * pre-pregnant BMI ≥ 28 and failed the 28 week oral glucose screening test * pre-pregnant BMI ≥ 28 and diagnosis of either A1 ("diet controlled") or A2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth. * pre-pregnant BMI ≥ 28 and diagnosed with type 2 diabetes during pregnancy * pre-pregnant BMI ≥ 30, and unmediated. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion criteria were selected to include only healthy infants of uncomplicated pregnancy (with the exception of gestational diabetes) and normal birth weight. The criteria for insulin resistance were strategically defined to capture the insulin-resistant population which represents a large proportion of the population that are at risk for diabetes but have not yet developed the disease. Insulin therapy is an exclusion criteria because it passes through the breast milk and we are unable to distinguish endogenous maternal insulin from exogenous therapeutic insulin in breast milk samples. These criteria will minimize the risks and increase the safety of subjects.
Key inclusion criteria (12 listed)
- Mothers ≥ 19 years of age
- Mothers intending to Exclusively Breastfeed for at least 5months
- Mothers comfortable with feeding their infants expressed breast milk from a bottle at 2-weeks postpartum
- Trial of labor (no scheduled C-sections)
- Singleton birth
Key exclusion criteria (7 listed)
- Scheduled C-sections or emergency C-sections with no labor (natural or induced)
- Maternal insulin therapy after birth
- Significant maternal health concern including type 1 diabetes, renal, kidney, thyroid, or cardiovascular disease, pre-eclampsia, or other disease.
- Delivery before 37 weeks
- Infant birth weight <2500g
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
mean infant postprandial C peptide to creatinine ratio
Time frame: 2 weeks
Postprandial urine (60-90 minute) will be tested for C peptide and creatinine and the ratio will be calculated.
1 secondary outcome
mean infant insulinogenic index
Time frame: 5 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 31 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Insulin Resistance and Obesity, run by University of Rochester at 1 site in United States.
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 12 inclusion and 7 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 31 Dec 2024. 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 United States. 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?
mean infant postprandial C peptide to creatinine ratio (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.