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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD100751-01 | U.S. NIH Grant/Contract | View source |
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The study could not be completed as planned due to difficulty to recruit moms during COVID.
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This purpose of this study is to investigate whether lactation improves insulin sensitivity and increases lipolysis in women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperinsulinemic-euglycemic clamp | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 hours |
| Triglycerides |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renate Belfort De Aguiar, MD, PhD | Assistant Professor of Medicine (Endocrinology) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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7 participants were screened and consented, 1 participant was screened and consented but did not qualify to be on study, demographics were collected from the 6 qualifying participants, with only 3 of those participants receiving intervention. The study could not be completed as planned due to difficulty to recruit moms during COVID.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Fed and Formula Fed | All participants that were breast or formula feeding |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Baseline characteristics presented here are for the 6 participants that were screened, consented and qualified.
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Feeding | 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. Hyperinsulinemic-euglycemic clamp: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data presented here is from the 3 participants that came to this appointment. | Posted | Mean | Standard Deviation | mg/kg/min | 2 hours and 4 hours |
|
4 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Feeding | 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. Hyperinsulinemic-euglycemic clamp: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renata Belfort De Aguiar, MD, PhD | Yale School of Medicine | (203) 785-5331 | renata.aguiar@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2022 | Nov 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2022 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
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. |
| 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. | 4 hours |
| BG001 | Formula Feeding | 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. Hyperinsulinemic-euglycemic clamp: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Systolic Blood Pressure (BP) | Mean | Standard Deviation | mmHg |
|
| Diastolic BP | Mean | Standard Deviation | mmHg |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Fat percentage | Mean | Standard Deviation | percentage of body fat |
|
| Fat Mass | Mean | Standard Deviation | kilograms |
|
| Fat Free Mass (FFM) | Mean | Standard Deviation | kilograms |
|
| Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Glucose Levels | Change in glucose from fasting baseline to 1 hour by Oral Glucose Tolerance Test (OGTT) | Mean | Standard Deviation | mg/dL |
|
| OG001 | Formula Feeding | 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. Hyperinsulinemic-euglycemic clamp: 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. |
|
|
| Primary | 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. | Data not collected due to COVID. | Posted | 4 hours |
|
|
| Primary | 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. | Data not collected due to COVID. | Posted | 4 hours |
|
|
| Secondary | 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. | Data not collected due to COVID. | Posted | 4 hours |
|
|
| Secondary | 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. | Data not collected due to COVID. | Posted | 4 hours |
|
|
| Secondary | 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. | Data not collected due to COVID. | Posted | 4 hours |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Formula Feeding | 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. Hyperinsulinemic-euglycemic clamp: 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. | 0 | 2 | 0 | 2 | 0 | 2 |
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