Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects
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ClinicalTrials.gov Identifier: NCT01257841 |
Recruitment Status :
Completed
First Posted : December 10, 2010
Last Update Posted : December 10, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Leptin administration Behavioral: Fasting | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Official Title: | Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women. |
Study Start Date : | November 2002 |
Actual Primary Completion Date : | December 2003 |
Actual Study Completion Date : | December 2003 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Fasting alone |
Behavioral: Fasting
Complete fasting, save for water and multivitamin, for four days. |
Active Comparator: Fasting plus leptin |
Drug: Leptin administration
Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days. Behavioral: Fasting Complete fasting, save for water and multivitamin, for four days. |
- Hormone levels change from baseline. [ Time Frame: Change from baseline after 4 days of intervention. ]Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion.
- Levels of inflammatory cytokines change from baseline. [ Time Frame: Change from baseline after 4 days of intervention. ]

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257841
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Massachusetts Institute of Technology | |
Cambridge, Massachusetts, United States, 02139 |
Principal Investigator: | Steven K Grinspoon, MD | Massachusetts General Hospital |
Responsible Party: | Steven K Grinspoon, M.D. Professor of Medicine, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01257841 |
Other Study ID Numbers: |
2002P-000518SA1 |
First Posted: | December 10, 2010 Key Record Dates |
Last Update Posted: | December 10, 2010 |
Last Verified: | December 2010 |
Fasting Gut hormones Inflammatory Cytokines |