Status:
COMPLETED
Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Massachusetts Institute of Technology
Conditions:
Healthy
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
The original study executed between 2002-2004 was an interventional trial in which 20, healthy, normal-weight female subjects were randomized to a four-day fast plus daily subcutaneous injections of l...
Eligibility Criteria
Inclusion
- female age 18-35
- BMI 20-26.0
- eumenorrheic with normal FSH, TSH, Prolactin
- Hgb \> 12 g/dL, normal creatinine
- normal puberty and development
- negative pregnancy test. In addition, subjects agreed not to be sexually active during the course of the inpatient study and to use contraception for a period of 48 hours after discharge from the hospital.
Exclusion
- medical or endocrine problems known to affect thyroid, reproductive, GH or cortisol function
- medications known to affect neuroendocrine function
- prior history of eating disorder or significant menstrual irregularities
- subjects who have a known hypersensitivity to E. Coli derived protein.
- subjects with a history of seizure disorder, significant cardiac disease, medication for cardiac disease, or kidney disease
- history of anaphylaxis or anaphylactoid like reactions.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01257841
Start Date
November 1 2002
End Date
December 1 2003
Last Update
December 10 2010
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139