GDMNCT04146909
The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women
A study testing Hyperinsulinemic-euglycemic clamp in people with GDM and Lactation, run by Yale University at 1 site in United States.
Trial summary
This purpose of this study is to investigate whether lactation improves insulin sensitivity and increases lipolysis in women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- Hyperinsulinemic-euglycemic clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- A history of GDM (as defined as the American Diabetes Association criteria)
- Delivered a singleton, live birth at ≥ 35 weeks gestation within the past 18 months
- HbA1C < 6.5% at time of screening
- Delivery within the past 18 months
- Breast Feed Group: exclusively or mostly breast-fed (< 6 ounces of formula/24 hours at 6-9 weeks of delivery) for at least 4-6 months
Who cannot join
- Currently lactating or lactation within the past 1 month at the time of the screening visit
- Diagnosis of diabetes (T1D or T2D) prior to pregnancy
- Current use of any glucose-lowering agents
- Pregnancy related medical problems including preeclampsia
- Major congenital fetal anomalies
- Creatinine > 1.5mg/dL, Hematocrit < 35%, ALT and AST > 2.5X upper limit of normal
Show all 11Show fewer
- Known psychiatric disorders, alcohol abuse, HIV, hepatitis, renal disease, hepatic disease, untreated heart disease, untreated thyroid disease, active systemic infection or malignancy
- Illicit drug use (by the participant's self-report)
- History of post-partum depression
- Use of weight loss supplements or dieting 6 months prior to study
- Corticosteroid or opiate use within 6 months of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
This purpose of this study is to investigate whether lactation improves insulin sensitivity and increases lipolysis in women.
Read the detailed description
There are two aims that this research will address.
In Aim 1, the research question is "Does lactation improve insulin sensitivity and increase lipolysis in women?" In this Aim, researchers will assess whether lactation amongst women with a history of gestational diabetes mellitus (GDM) will improve whole body insulin sensitivity as well as increase whole body lipid turnover by using hyperinsulinemic-euglycemic clamps combined with [6,6-2H]-glucose and [2H5]-glycerol infusions. These stable, non-radiating isotopes have been used extensively and safely to study the mechanisms of insulin resistance amongst non-pregnant as well as pregnant humans; however, these techniques have not previously been applied to the study of insulin sensitivity during lactation. Therefore, the goals will be two-fold: 1) to determine whether lactation induces similar changes in insulin sensitivity in humans as in mice and 2) to pilot the feasibility of performing larger, more detailed metabolic studies in this population of women post-partum.
The second aim (Aim 2) will use a retrospective chart review of women with a history of GDM who had an oral glucose tolerance test (OGTT) 6-8 weeks post-partum as part of standard of care.
The focus of this protocol registration will be Aim 1.
- Being tested
- Hyperinsulinemic-euglycemic clamp
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic-euglycemic clampDiagnostic test
After an overnight fast and an equilibration period lasting 2 hours, the 2-step euglycemic-hyperinsulinemic clamp study will be performed. A primed-continuous infusion of regular insulin will be given at 8 mU/(m2 × min) during the first 2 hours, and increased to 40 mU/(m2 × min) for the subsequent 2 hours. Plasma glucose levels will be measured every 5 min, and a variable glucose infusion will be initiated to maintain levels at ∼90 mg/dl. Plasma samples will be drawn at baseline and throughout the infusion period for measurement of isotope enrichment, insulin, NEFA, glycerol turnover, and additional hormones which may be altered with lactation. Approximately 160 mL of blood will be drawn at this visit.
| Study group | Role | What they receive |
|---|---|---|
| Breast Feeding | Active comparator | This group will consist of women who exclusively or mostly breast-fed for at least 4-6 months (< 6 ounces of formula/24 hours at 6-9 weeks of delivery)1 and who delivered within the past 18 months. Receives: Diagnostic Test: Hyperinsulinemic-euglycemic clamp |
| Formula Feeding | Active comparator | This group will consist of women who exclusively or mostly formula-fed (no breastfeeding or < 3 weeks of breastfeeding)1 and who delivered within the past 18 months. Receives: Diagnostic Test: Hyperinsulinemic-euglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Body Insulin Sensitivity Measured by the Glucose Infusion Rate
The glucose infusion rate is determined by the amount of 20% dextrose given during the hyperinsulinemic-euglycemic clamp study, necessary to keep blood glucose levels at the target range (90-100 mg/dL). Higher rates of infused dextrose indicates greater sensitivity to infused insulin during the hyperinsulinemic-euglycemic clamp. Women with gestational diabetes are expected to be insulin resistant.
Measured: 2 hours and 4 hours
Endogenous Glucose Production
Determined with [6,6-2H] Glucose tracer given during the hyperinsulinemic-euglycemic clamp study. Lower values of endogenous glucose production indicates greater hepatic insulin sensitivity.
Measured: 4 hours
Whole Body Lipid Turnover Rates
Determined with [2H5] Glycerol tracer given during the hyperinsulinemic-euglycemic clamp study. Tracer levels in the plasma determinates how the body uses fat in the blood during the hyperinsulinemic-euglycemic clamp study.
Measured: 4 hours
Secondary outcomes (3)
Plasma NEFA
Measurement of non-esterified fatty acids levels in the plasma at fasting and during the hyperinsulinemic-euglycemic clamp study. NEFA levels in the plasma are higher in individuals less sensitive to the effects of insulin.
Measured: 4 hours
Triglycerides
Measurement of triglycerides levels in the plasma at fasting and during the hyperinsulinemic-euglycemic clamp study. Triglycerides levels in the plasma are higher in individuals less sensitive to the effects of insulin and with type 2 diabetes.
Measured: 4 hours
Insulin Levels
Measurement of insulin levels in the plasma at fasting and during the hyperinsulinemic-euglycemic clamp study. Insulin levels in the plasma are higher in insulin resistant individuals.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start17 Nov 2020
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Why it stopped: The study could not be completed as planned due to difficulty to recruit moms during COVID.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GDMStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Renate Belfort De Aguiar, MD, PhD, Principal investigator, Assistant Professor of Medicine (Endocrinology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146909
- Sponsor's protocol ID
- 2000025731
- Other IDs
- 1R21HD100751-01
- Status last verified
- Feb 2024
- First submitted
- 29 Oct 2019
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women
- ClinicalTrials.gov ID
- NCT04146909
- Acronym / sponsor ID
- 2000025731
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study could not be completed as planned due to difficulty to recruit moms during COVID.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to investigate whether lactation improves insulin sensitivity and increases lipolysis in women.
Detailed description
There are two aims that this research will address.
In Aim 1, the research question is "Does lactation improve insulin sensitivity and increase lipolysis in women?" In this Aim, researchers will assess whether lactation amongst women with a history of gestational diabetes mellitus (GDM) will improve whole body insulin sensitivity as well as increase whole body lipid turnover by using hyperinsulinemic-euglycemic clamps combined with [6,6-2H]-glucose and [2H5]-glycerol infusions. These stable, non-radiating isotopes have been used extensively and safely to study the mechanisms of insulin resistance amongst non-pregnant as well as pregnant humans; however, these techniques have not previously been applied to the study of insulin sensitivity during lactation. Therefore, the goals will be two-fold: 1) to determine whether lactation induces similar changes in insulin sensitivity in humans as in mice and 2) to pilot the feasibility of performing larger, more detailed metabolic studies in this population of women post-partum.
The second aim (Aim 2) will use a retrospective chart review of women with a history of GDM who had an oral glucose tolerance test (OGTT) 6-8 weeks post-partum as part of standard of care.
The focus of this protocol registration will be Aim 1.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Feeding | Active comparator | Diagnostic Test: Hyperinsulinemic-euglycemic clampThis group will consist of women who exclusively or mostly breast-fed for at least 4-6 months (< 6 ounces of formula/24 hours at 6-9 weeks of delivery)1 and who delivered within the past 18 months. |
| Formula Feeding | Active comparator | Diagnostic Test: Hyperinsulinemic-euglycemic clampThis group will consist of women who exclusively or mostly formula-fed (no breastfeeding or < 3 weeks of breastfeeding)1 and who delivered within the past 18 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A history of GDM (as defined as the American Diabetes Association criteria)
- Delivered a singleton, live birth at ≥ 35 weeks gestation within the past 18 months
- HbA1C < 6.5% at time of screening
- Delivery within the past 18 months
- Breast Feed Group: exclusively or mostly breast-fed (< 6 ounces of formula/24 hours at 6-9 weeks of delivery) for at least 4-6 months
Key exclusion criteria (11 listed)
- Currently lactating or lactation within the past 1 month at the time of the screening visit
- Diagnosis of diabetes (T1D or T2D) prior to pregnancy
- Current use of any glucose-lowering agents
- Pregnancy related medical problems including preeclampsia
- Major congenital fetal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinsulinemic-euglycemic clampAfter an overnight fast and an equilibration period lasting 2 hours, the 2-step euglycemic-hyperinsulinemic clamp study will be performed. A primed-continuous infusion of regular insulin will be given at 8 mU/(m2 × min) during the first 2 hours, and increased to 40 mU/(m2 × min) for the subsequent 2 hours. Plasma glucose levels will be measured every 5 min, and a variable glucose infusion will be initiated to maintain levels at ∼90 mg/dl. Plasma samples will be drawn at baseline and throughout the infusion period for measurement of isotope enrichment, insulin, NEFA, glycerol turnover, and additional hormones which may be altered with lactation. Approximately 160 mL of blood will be drawn at this visit. | Diagnostic test | Breast Feeding, Formula Feeding |
Primary outcome
Whole Body Insulin Sensitivity Measured by the Glucose Infusion Rate
Time frame: 2 hours and 4 hours
The glucose infusion rate is determined by the amount of 20% dextrose given during the hyperinsulinemic-euglycemic clamp study, necessary to keep blood glucose levels at the target range (90-100 mg/dL). Higher rates of infused dextrose indicates greater sensitivity to infused insulin during the hyperinsulinemic-euglycemic clamp. Women with gestational diabetes are expected to be insulin resistant.
Endogenous Glucose Production
Time frame: 4 hours
Determined with [6,6-2H] Glucose tracer given during the hyperinsulinemic-euglycemic clamp study. Lower values of endogenous glucose production indicates greater hepatic insulin sensitivity.
Whole Body Lipid Turnover Rates
Time frame: 4 hours
Determined with [2H5] Glycerol tracer given during the hyperinsulinemic-euglycemic clamp study. Tracer levels in the plasma determinates how the body uses fat in the blood during the hyperinsulinemic-euglycemic clamp study.
3 secondary outcomes
Plasma NEFA
Time frame: 4 hours
Triglycerides
Time frame: 4 hours
Insulin Levels
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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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.
Renate Belfort De Aguiar, MD, PhD principal investigator
Assistant Professor of Medicine (Endocrinology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulinemic-euglycemic clamp in people with GDM and Lactation, run by Yale University 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 Feb 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?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Whole Body Insulin Sensitivity Measured by the Glucose Infusion Rate (time frame: 2 hours and 4 hours). The study lists 3 primary outcomes in all. 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 15 Feb 2024.