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| Name | Class |
|---|---|
| Santa Clara Valley Medical Center | OTHER |
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The investigators hope to learn whether treatment with medical nutrition therapy (MNT) for pregnant women with prediabetes decreases the rate and severity of impaired glucose tolerance later in pregnancy and improves perinatal outcomes. Given the rising rates of obesity and diabetes in this country even among young women and the adverse affects of diabetes of pregnant women and their infants, the investigators feel that it is important to not only identify women at high risk for diabetes early in pregnancy but determine the appropriate management strategy
INTAKE VISIT: A health professional performs this visit soon after the diagnosis of pregnancy. Standardized glycosylated hemoglobin (A1C)is drawn as part of the routine prenatal panel at the above institutions. Women with an A1C of >6.5% are categorized as having type 2 diabetes, excluded from randomization, and referred for medical nutrition therapy, blood glucose monitoring, and insulin as needed. Women with an initial A1C <5.7% will receive routine prenatal care by their usual providers and will be screened for gestational diabetes Mellitus (GDM) in the second trimester per routine. Standard treatment for both these diabetic groups will be provided independently of this study, but anonymous outcome data will be available via hospital perinatal databases. Women with an A1c of 5.7-6.4% are eligible for the study.
EARLY PRENATAL VISIT: women with an A1C of 5.7-6.4% will be informed by their providers that they fall into a group labeled "prediabetes" outside of pregnancy and will be invited to learn about the study. All prediabetic women (agreeing to enroll or not) will be informed about general health risks and appropriate weight gain during pregnancy. Women who enroll will be queried regarding basic demographic information, pre-pregnancy weight, height, and obstetric and family history. Standardized weight, blood pressure (BP), and body mass index (BMI) will be recorded. Participants will be given a 1-page survey regarding their knowledge of risk factors for diabetes, appropriate weight gain in pregnancy, and the benefits of breastfeeding.
RANDOMIZATION AND MANAGEMENT: Women who enroll by 13 weeks gestation will be stratified by BMI < 30 or > 30 and randomized to either:
Diet: Regular visits with a dietitian every 2 weeks emphasizing a food and beverage plan (Institute of Medicine standards) of appropriate energy and no more than 45% carbohydrate; limited saturated fat; adequate protein, mineral and vitamin intake; and portion control by 'carbohydrate counting'. Food and beverage intake will be divided into 3 meals and 3 snacks and self-recorded on daily food records. Recommended choices of foods and carbohydrate type will take into account personal and cultural preferences. Standardized weight will be measured and charted at each visit. The MNT plan will be adjusted according to maternal weight gain and ongoing glycemic levels. Participants will continue the MNT plan until delivery, and it will be adjusted postpartum for the needs of breastfeeding. Furthermore this group will be treated with:
A. EXERCISE: Participants will be encouraged to exercise with a minimum of brisk walking for 30 minutes each day (often 10 minutes after each meal).
B. SELF BLOOD GLUCOSE MONITORING: Participants will perform finger sticks four times each day (fasting and 1-hour after starting breakfast, lunch, and dinner) and self-recording of these values. At study visits the accuracy of the written records will be compared to the meter memory, and the glucose values will be downloaded for later analysis. The One Touch Delica and UltraMini self-monitoring of blood glucose (SMBG) system will be used and the meter, lancets and strips will be provided free of charge to the participants.
C. INSULIN: Participants will be started on insulin therapy by standard methods if more than 25% of fasting finger sticks are greater than 99 mg/dL or 1-hour post prandial finger sticks are greater than 135 mg/dL over a 2-week interval.
26 WEEKS GESTATION: Participants in both groups will be assessed for weight gain and blood pressure, and they will complete a 75-g, 2-hr oral glucose tolerance test (OGTT) (2H GTT). Those in the minimal intervention group with one or more abnormal value by ADA standards will be treated for GDM. No additional intervention will be given to women in the treatment group since will already be receiving treatment. In this study, we have chosen to use the 2H GTT as it has been correlated with adverse perinatal outcomes as described by the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study group.
DELIVERY: Recommendations for timing of delivery, management of labor, and route of delivery will be made by usual obstetric care providers independent of study personnel. All participants will have A1C measured as an indicator of late pregnancy glycemic control. Umbilical cord blood will be collected on all participants to evaluate levels of c-peptide. Elevated c-peptide is a measure of fetal hyperinsulinemia and a marker of fetopathy24. Delivery and neonatal data will be collected (see below). Participants will be instructed to continue the diet therapy for at least 6 months postpartum
6-WEEK POSTPARTUM VISIT: All participants will undergo a 2H GTT and have A1C checked. Their weight will be recorded and compared to pre-pregnancy weight. Breastfeeding will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment for glucose intolerance | Active Comparator | Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary. |
|
| Minimum intervention control group | Active Comparator | Single visit with dietician or health educator followed by routine care per provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimum intervention control group | Other | A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation. | Diagnosis based on criteria recommended by the ADA (Oral GTT with one abnormal value, fasting greater than or equal to 92, on hour greater than or equal to 180, two hour greater than or equal to 153) | 26 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Different Modes of Delivery | Modes of delivery investigated were: cesarean delivery, vaginal delivery, assisted vaginal delivery, spontaneous delivery and termination of pregnancy. | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Number of Participants With Excessive Gestational Weight Gain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Y El-Sayed, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Clara Valley Medical Center | San Jose | California | 95108 | United States | ||
| Stanford University School of Medicine/Lucile Packard Childrens Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment for Glucose Intolerance | Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary. Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary |
| FG001 | Minimum Intervention Control Group | Single visit with dietician or health educator followed by routine care per provider. Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment for Glucose Intolerance | Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary. Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary |
| BG001 | Minimum Intervention Control Group |
| 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 | Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation. | Diagnosis based on criteria recommended by the ADA (Oral GTT with one abnormal value, fasting greater than or equal to 92, on hour greater than or equal to 180, two hour greater than or equal to 153) | Posted | Count of Participants | Participants | 26 weeks of gestation |
|
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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 | Treatment for Glucose Intolerance | Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary. Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intrauterine Fetal Demise | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Girsen, Research Operations Manager | Stanford University, School of Medicine | (650) 725-5720 | agirsen@stanford.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment for glucose intolerance | Other | Diet, exercise glucose monitoring, insulin if necessary |
|
Excessive weight gain greater than the Institute of Medicine guidelines |
| Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Mean Hemoglobin A1C Value at Delivery | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Mean Fasting Triglyceride Level | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Number of Patients With Gestational Hypertension | Hypertensive disorder in pregnancy with blood pressure greater than or equal to 140/90 after 20 weeks gestation | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Number of Patients With Pre-eclampsia | Blood pressure greater than or equal to 140/90 with 300 mg of protein on a 24-hour urine collection. | Up to 6 weeks after delivery |
| Mean Level of Postpartum Oral Glucose-tolerance-test at 6 Weeks Postpartum | 6 weeks after delivery |
| Number of Participants With Need for Insulin Therapy | Insulin required during pregnancy | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Mean Neonatal Birth Weight | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Mean Ponderal Index | The Corpulence Index (CI) or Ponderal Index (PI) is a measure of leanness (corpulence) of a person calculated as a relationship between mass and height. | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Mean Level of Umbilical Cord C-peptide >=90th Percentile in the Whole Cohort | C-peptide test is a tool for monitoring and treating diabetes. | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
| Number of Participants With Neonatal Hypoglycemia | Infants treated for neonatal hypoglycemia-- Glucose of <36 mg/dl; <2 millimoles (mM) | 1 week after delivery |
| Number of Participants With Neonatal Hyperbilirubinemia | Neonates treated for hyperbilirubinemia | 1 week after delivery |
| Number of Participants With Intrauterine Fetal Demise | Duration of pregnancy and up to 28 days after delivery |
| Stanford |
| California |
| 94305 |
| United States |
Single visit with dietician or health educator followed by routine care per provider. Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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|
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| Secondary | Number of Participants With Different Modes of Delivery | Modes of delivery investigated were: cesarean delivery, vaginal delivery, assisted vaginal delivery, spontaneous delivery and termination of pregnancy. | Participants with available data included in the analysis. | Posted | Count of Participants | Participants | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
|
|
|
| Secondary | Number of Participants With Excessive Gestational Weight Gain | Excessive weight gain greater than the Institute of Medicine guidelines | Participants with available data included in the analysis. | Posted | Count of Participants | Participants | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
|
|
|
| Secondary | Mean Hemoglobin A1C Value at Delivery | Participants with available data included in the analysis. | Posted | Mean | Standard Deviation | percent | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
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|
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| Secondary | Mean Fasting Triglyceride Level | Participants with available data included in the analysis. | Posted | Mean | Standard Deviation | mg/dL | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
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|
|
| Secondary | Number of Patients With Gestational Hypertension | Hypertensive disorder in pregnancy with blood pressure greater than or equal to 140/90 after 20 weeks gestation | Participants with available data included in the analysis. | Posted | Count of Participants | Participants | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
|
|
|
| Secondary | Number of Patients With Pre-eclampsia | Blood pressure greater than or equal to 140/90 with 300 mg of protein on a 24-hour urine collection. | Participants with available data included in the analysis. | Posted | Count of Participants | Participants | Up to 6 weeks after delivery |
|
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|
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| Secondary | Mean Level of Postpartum Oral Glucose-tolerance-test at 6 Weeks Postpartum | Participants with available data included in the analysis. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks after delivery |
|
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| Secondary | Number of Participants With Need for Insulin Therapy | Insulin required during pregnancy | Participants with available data included in the analysis. | Posted | Count of Participants | Participants | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
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| Secondary | Mean Neonatal Birth Weight | Participants with available data included in the analysis. | Posted | Mean | Standard Deviation | grams | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
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|
|
| Secondary | Mean Ponderal Index | The Corpulence Index (CI) or Ponderal Index (PI) is a measure of leanness (corpulence) of a person calculated as a relationship between mass and height. | Participants with available data included in the analysis. | Posted | Mean | Standard Deviation | kg/m3 | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
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|
|
| Secondary | Mean Level of Umbilical Cord C-peptide >=90th Percentile in the Whole Cohort | C-peptide test is a tool for monitoring and treating diabetes. | Participants with available data included in the analysis. | Posted | Count of Participants | Participants | Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation |
|
|
|
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| Secondary | Number of Participants With Neonatal Hypoglycemia | Infants treated for neonatal hypoglycemia-- Glucose of <36 mg/dl; <2 millimoles (mM) | Participants with available data included in the analysis. | Posted | Count of Participants | Participants | 1 week after delivery |
|
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| Secondary | Number of Participants With Neonatal Hyperbilirubinemia | Neonates treated for hyperbilirubinemia | Participants with available data included in the analysis. | Posted | Count of Participants | Participants | 1 week after delivery |
|
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|
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| Secondary | Number of Participants With Intrauterine Fetal Demise | Posted | Count of Participants | Participants | Duration of pregnancy and up to 28 days after delivery |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Minimum Intervention Control Group | Single visit with dietician or health educator followed by routine care per provider. Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider. | 1 | 45 | 0 | 45 |
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| Assisted vaginal |
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| Spontaneous abortion |
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| Termination |
|