Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2010

Last Updated Date

December 9, 2010

Start Date ^ICMJE

November 2002

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hormone levels change from baseline. [ Time Frame: Change from baseline after 4 days of intervention. ] [ Designated as safety issue: No ]

Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01257841 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Levels of inflammatory cytokines change from baseline. [ Time Frame: Change from baseline after 4 days of intervention. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

Official Title ^ICMJE

Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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.

Study Arm (s)

Placebo Comparator: Fasting alone
Intervention: Behavioral: Fasting
Active Comparator: Fasting plus leptin
Interventions:
- Drug: Leptin administration
- Behavioral: Fasting

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2003

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01257841

Other Study ID Numbers ^ICMJE

2002P-000518SA1

Has Data Monitoring Committee

Yes

Responsible Party

Steven K Grinspoon, M.D. Professor of Medicine, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Massachusetts Institute of Technology

Investigators ^ICMJE

Principal Investigator:

Steven K Grinspoon, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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