SOLICITATION NOTICE
Q -- Offspring Study
- Notice Date
- 2/9/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2011-92239
- Archive Date
- 3/11/2011
- Point of Contact
- Ivory Y Reid, Phone: 7704882452
- E-Mail Address
-
ireid@cdc.gov
(ireid@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- I. BACKGROUND AND NEED - GDM affects 2% to 10% of pregnancies in the United States. Although carbohydrate intolerance usually resolves after delivery, up to one-third of affected women will have diabetes or impaired glucose metabolism at postpartum screening, and it has been estimated that 15% to 50% will develop diabetes in the decades following the affected pregnancy. However, there is now strong evidence that interventions such as lifestyle modification and pharmacotherapy can prevent or delay the development of disease in high-risk individuals, including women with a history of GDM. In addition, hyperglycemia in pregnancy has been associated with later obesity in offspring. However, it is unknown how the timing and intensity of the hyperglycemia or other related factors might influence offspring outcomes. Previous studies of long-term outcomes of women with GDM and their offspring have been limited by a number of factors. In most studies, the results of post-partum screening for diabetes are unknown, making it difficult to separate women with undiagnosed preexisting diabetes from those with GDM. Studies of offspring fail to account for lifestyle factors after pregnancy, such as infant diet. II. PURPOSE The purpose of this study is to identify biomarkers that predict diabetes in women with recent GDM-affected pregnancies and growth in the offspring in the 1st year of life. The Study of Women, Infant Feeding and Type 2 Diabetes (SWIFT) is a prospective observational study of women with recent GDM and without diabetes at 6-8 weeks postpartum. SWIFT examines the 2-year incidence of type 2 diabetes among women with recent GDM based on annual screening with the 2-hour 75 g OGTT. The SWIFT Offspring Study examines growth patterns by infant feeding method among infants of SWIFT mothers. For the proposed work, maternal baseline biomarkers (plasma lipid profiles, adipocytokines, and hormones) and indicators of glycemic control (hemoglobin A1c [HbA1c], glycated albumin [GA], and fructosamine) will be examined as potential predictors of future diabetes and of growth in offspring. In addition, saliva samples will be collected from the infants for future genetic studies. III. SCOPE OF WORK We propose to secure services to analyze samples from 600 women for the following: lipid profile, adiponectin c-reactive protein (CRP), leptin, sex hormone binding globulin (SHBG), glycated albumin (GA), fructosamine, hemoglobin A1c (HbA1c), prolactin, and complete blood count, as well as to collect saliva from 325 offspring for storage for future analysis (Saliva Oragene Kit for offspring). The information generated from these analyses will be used to identify biomarkers that predict diabetes in women with recent GDM pregnancies and growth in the offspring in the 1st year of life. Findings from this work will provide new information regarding risk factors that may predict incident type 2 diabetes after a GDM pregnancy in a large, racially and ethnically diverse cohort. The collection of saliva from offspring will allow the investigators to conduct studies of genetic contributions to growth in offspring in the future. After this one-year, non-severable contract, CDC will not have further requirements from this vendor for this study. IV. TASKS TO BE PERFORMED The vendor will provide all labor required to complete the tasks outlined below. 1. Obtain samples and transport to designated laboratory for analysis. 2. Use plasma samples (already collected and stored at -70°C) from 600 women to conduct the following assays: a. Lipid profile, fasting and complete b. Adiponectin c. C-reactive protein (CRP) d. Leptin Sex hormone binding globulin (SHBG) e. Glycated albumin (GA) f. Fructosamine g. Hemoglobin A1c (HbA1c) h. Prolactin i. Complete Blood Count. 3. Send aggregate results to CDC in the form of a report. 4. Collect saliva from offspring (n=325) for future analysis, using Saliva Oragene Kits. 5. Send documentation of completion of saliva sample collection and storage to CDC. V. GOVERNMENT FURNISHED MATERIALS N/A VI. PERIOD OF PERFORMANCE The period of performance shall commence upon award of a contract and shall continue through September 30, 2012 or until all activities are complete, whichever is sooner. VII. DELIVERABLES The vendor shall provide the following deliverables to the Project Officer by the dates reflected below. DELIVERABLE BUDGET ACTIVITY DUE (MONTHS AFTER THE AWARD) Documentation that samples for analysis have been identified and transported to designated laboratory for analysis. Month 2 Documentation that assays have been completed in the form of a report including results based on aggregated data Month 11 Documentation of successful collection of saliva samples from offspring Month 12 VII. MINIMUM VENDOR QUALIFICATIONS The vendor shall have expertise in the health consequences of gestational diabetes. The vendor shall have experience conducting prospective observational studies in pregnant women. The vendor shall have access to banked specimens from a cohort of women with GDM, information on outcomes including results of postpartum follow up evaluations, and on important potential confounders, such as breastfeeding. The vendor shall have staff, facilities and infrastructure necessary to retrieve samples and analyze data. The vendor shall have a lead investigator who will supervise research scientists, analysts, and other personnel.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2011-92239/listing.html)
- Place of Performance
- Address: NCCDPHP/Division of Reproductive Health, 2900 Woodcock Blvd, Atlanta, Georgia, 30341, United States
- Zip Code: 30341
- Zip Code: 30341
- Record
- SN02376585-W 20110211/110209234528-d458703859a6335378acd5b7a9bd2323 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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