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Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

NCT ID: NCT01257841

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-12-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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Fasting Gut hormones Inflammatory Cytokines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fasting alone

Group Type PLACEBO_COMPARATOR

Fasting

Intervention Type BEHAVIORAL

Complete fasting, save for water and multivitamin, for four days.

Fasting plus leptin

Group Type ACTIVE_COMPARATOR

Leptin administration

Intervention Type DRUG

Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.

Fasting

Intervention Type BEHAVIORAL

Complete fasting, save for water and multivitamin, for four days.

Interventions

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Leptin administration

Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.

Intervention Type DRUG

Fasting

Complete fasting, save for water and multivitamin, for four days.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts Institute of Technology

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Principal Investigators

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Steven K Grinspoon, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

References

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Canavan B, Salem RO, Schurgin S, Koutkia P, Lipinska I, Laposata M, Grinspoon S. Effects of physiological leptin administration on markers of inflammation, platelet activation, and platelet aggregation during caloric deprivation. J Clin Endocrinol Metab. 2005 Oct;90(10):5779-85. doi: 10.1210/jc.2005-0780. Epub 2005 Aug 2.

Reference Type RESULT
PMID: 16076944 (View on PubMed)

Schurgin S, Canavan B, Koutkia P, Depaoli AM, Grinspoon S. Endocrine and metabolic effects of physiologic r-metHuLeptin administration during acute caloric deprivation in normal-weight women. J Clin Endocrinol Metab. 2004 Nov;89(11):5402-9. doi: 10.1210/jc.2004-1102.

Reference Type RESULT
PMID: 15531489 (View on PubMed)

Koutkia P, Schurgin S, Berry J, Breu J, Lee BS, Klibanski A, Grinspoon S. Reciprocal changes in endogenous ghrelin and growth hormone during fasting in healthy women. Am J Physiol Endocrinol Metab. 2005 Nov;289(5):E814-22. doi: 10.1152/ajpendo.00093.2005. Epub 2005 Jun 21.

Reference Type RESULT
PMID: 15972272 (View on PubMed)

Other Identifiers

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2002P-000518SA1

Identifier Type: -

Identifier Source: org_study_id