Clinical trial NCT01257841: Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects
Official title: Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Fasting
Gut hormones
Inflammatory Cytokines
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2010-12-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: Hormone levels change from baseline.
timeFrame: Change from baseline after 4 days of intervention.
Secondary outcomes:
measure: Levels of inflammatory cytokines change from baseline.
timeFrame: Change from baseline after 4 days of intervention.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cambridge
country: United States
facility: Massachusetts Institute of Technology
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven K Grinspoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.