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| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting alone | Placebo Comparator |
| |
| Fasting plus leptin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leptin administration | Drug | Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of inflammatory cytokines change from baseline. | Change from baseline after 4 days of intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven K Grinspoon, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Massachusetts Institute of Technology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16076944 | Result | 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. | |
| 15531489 |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
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| Fasting | Behavioral | Complete fasting, save for water and multivitamin, for four days. |
|
| Cambridge |
| Massachusetts |
| 02139 |
| United States |
| 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. |
| 15972272 | Result | 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. |