NCT01257841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2002

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

1.1 years

First QC Date

December 7, 2010

Last Update Submit

December 9, 2010

Conditions

Healthy

Keywords

FastingGut hormonesInflammatory Cytokines

Outcome Measures

Primary Outcomes (1)

  • Hormone levels change from baseline.

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

    Change from baseline after 4 days of intervention.

Secondary Outcomes (1)

  • Levels of inflammatory cytokines change from baseline.

    Change from baseline after 4 days of intervention.

Study Arms (2)

Fasting alone

PLACEBO COMPARATOR
Behavioral: Fasting

Fasting plus leptin

ACTIVE COMPARATOR
Drug: Leptin administrationBehavioral: Fasting

Interventions

Leptin administrationDRUG

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

Fasting plus leptin
FastingBEHAVIORAL

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

Fasting aloneFasting plus leptin

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (3)

  • 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.

    PMID: 16076944RESULT

  • 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.

    PMID: 15531489RESULT

  • 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.

    PMID: 15972272RESULT

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Steven K Grinspoon, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 10, 2010

Study Start

November 1, 2002

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

December 10, 2010

Record last verified: 2010-12

Locations

US(2)