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Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborator:
Massachusetts Institute of Technology
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01257841
First received: December 7, 2010
Last updated: December 9, 2010
Last verified: December 2010
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Purpose
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 | Intervention |
|---|---|
| Healthy | Drug: Leptin administration Behavioral: Fasting |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) |
| Official Title: | Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women. |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
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. ]
| Enrollment: | 20 |
| Study Start Date: | November 2002 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01257841
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications:
| 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 |
| Study First Received: | December 7, 2010 |
| Last Updated: | December 9, 2010 |
Keywords provided by Massachusetts General Hospital:
|
Fasting Gut hormones Inflammatory Cytokines |
Additional relevant MeSH terms:
|
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 26, 2017