Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects
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| ClinicalTrials.gov Identifier: NCT01257841 |
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Recruitment Status :
Completed
First Posted : December 10, 2010
Last Update Posted : December 10, 2010
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Sponsor:
Massachusetts General Hospital
Collaborator:
Massachusetts Institute of Technology
Information provided by:
Massachusetts General Hospital
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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 leptin or a four day fast plus daily subcutaneous injections of a placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid function, and cortisol secretion. The current study is a secondary analysis focussed on the placebo group which underwent a four-day fast. The study is looking at the effects of fasting on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The hypothesis for this secondary analysis was that four days of fasting would augment levels of orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones, while suppressing secretion of inflammatory cytokines.
| 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. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 |
Criteria
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.
Information from the National Library of Medicine
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
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Massachusetts Institute of Technology | |
| Cambridge, Massachusetts, United States, 02139 | |
Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Institute of Technology
Investigators
| Principal Investigator: | Steven K Grinspoon, MD | Massachusetts General Hospital |
Publications of Results:
| Responsible Party: | Steven K Grinspoon, M.D. Professor of Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01257841 History of Changes |
| Other Study ID Numbers: |
2002P-000518SA1 |
| First Posted: | December 10, 2010 Key Record Dates |
| Last Update Posted: | December 10, 2010 |
| Last Verified: | December 2010 |
Keywords provided by Massachusetts General Hospital:
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Fasting Gut hormones Inflammatory Cytokines |
Additional relevant MeSH terms:
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Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |