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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.
Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts in the brain to decrease appetite and increase long term energy usage. Leptin levels usually go down when people are not eating for extended periods of time. Changes in metabolism and certain hormone levels also occur with fasting. By studying the pharmacokinetics of leptin administration, we can evaluate the changes of leptin levels in response to giving different doses of leptin as well as acute changes of other hormones in response to leptin levels. Investigations such as this one have important implications for the future therapeutic use of leptin, including determining the appropriate dose of leptin to use in future studies involving leptin administration.
Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed state or fasting state | Experimental | 1-day fed studies with administration of r-metHuLeptin at three different doses (0.01 mg/kg, 0.1 mg/kg, 0.3 mg/kg). All subjects participated in 3 studies in the fed condition (Part A) and 3 separate 72-hour fasting studies. Intervention administered was-r-metreleptin in 3 different doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| r-metHuLeptin | Drug | r-metreleptin was given in 3 different dose in fed and fasting states |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg | 72-hour fasting Day 3 Leptin dose 0.01 mg/kg | 3 DAY |
| Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg | 72-hour fasting Day 3 Leptin dose 0.01 mg/kg | 3 DAY |
| Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg | 72-hour fasting Day 3 Leptin dose 0.01 mg/kg | 3 DAY |
| Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg | 72-hour fasting Day 3 Leptin dose 0.1 mg/kg | 3 DAY |
| Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg | 72-hour fasting Day 3 Leptin dose 0.1 mg/kg | 3 DAY |
| Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg | 72-hour fasting Day 3 Leptin dose 0.1 mg/kg | 3 DAY |
| Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg | 72-hour fasting Day 3 Leptin dose 0.3 mg/kg | 3 DAY |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) | Data were collected neither in Fed nor in Fasting state for the different doses of leptin | 1 DAY or DAY 3 |
| Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christos S Mantzoros, MD DSc FACP FACE | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35820631 | Derived | Bouzoni E, Perakakis N, Connelly MA, Angelidi AM, Pilitsi E, Farr O, Stefanakis K, Mantzoros CS. PCSK9 and ANGPTL3 levels correlate with hyperlipidemia in HIV-lipoatrophy, are regulated by fasting and are not affected by leptin administered in physiologic or pharmacologic doses. Metabolism. 2022 Sep;134:155265. doi: 10.1016/j.metabol.2022.155265. Epub 2022 Jul 9. | |
| 33051459 |
| Label | URL |
|---|---|
| Click here for more information about the Mantzoros Research Group. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 LEAN MEN Fasting State (72 Hrs) on 0.3mg/kg Leptin | 5 lean men were fasted for 72 hrs and during that period recieved 0.3mg/kg leptin |
| FG001 | 5 OBESE MEN 72 HR FASTING on 0.3mg/kg Leptin | 5 obese men were fasted for 72 hrs and during that period received 0.3mg/kg leptin |
| FG002 | 5 LEAN WOMEN 72 HR FATSING on 0.3mg/kg Leptin | 5 lean women were fasted for 72 hrs and during that period received 0.3mg/kg leptin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEAN MEN 24h Fed or 72h Fasting in Different Leptin Doses | 5 lean men were fasted for 72 hrs and during that period received 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit) |
| BG001 | OBESE MEN 24h Fed or 72h Fasting in Different Leptin Doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg | 72-hour fasting Day 3 Leptin dose 0.01 mg/kg | Posted | Mean | Standard Deviation | HR | 3 DAY |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fasting State (72 Hrs) | 0 | 15 |
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small size population, results cannot be generalized
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christos mantzoros | BIDMC | 6176671656 | cmantzor@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C122136 | recombinant methionyl human leptin |
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| Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg | 72-hour fasting Day 3 Leptin dose 0.3 mg/kg | 3 DAY |
| Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg | 72-hour fasting Day 3 Leptin dose 0.3 mg/kg | 3 DAY |
| Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg | 24-hour fed Leptin dose 0.3 mg/kg | 1 DAY |
| Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg | 24-hour fed Leptin dose 0.3 mg/kg | 1 DAY |
| Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg | 24-hour fed Leptin dose 0.3 mg/kg | 1 DAY |
| Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg | 24-hour fed Leptin dose 0.01 mg/kg | 1 DAY |
| Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg | 24-hour fed Leptin dose 0.01 mg/kg | 1 DAY |
| Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg | 24-hour fed Leptin dose 0.01 mg/kg | 1 DAY |
| Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg | 24-hour fed Leptin dose 0.1 mg/kg | 1 DAY |
| Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg | 24-hour fed Leptin dose 0.1 mg/kg | 1 DAY |
| Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg | 24-hour fed Leptin dose 0.1 mg/kg | 1 DAY |
Data were collected neither in Fed nor in Fasting state for the different doses of leptin |
| 1 DAY or DAY 3 |
| Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) | Data were collected neither in Fed nor in Fasting state for the different doses of leptin | day 3 of fasting and day 1 of fed state |
| Chrysafi P, Perakakis N, Farr OM, Stefanakis K, Peradze N, Sala-Vila A, Mantzoros CS. Leptin alters energy intake and fat mass but not energy expenditure in lean subjects. Nat Commun. 2020 Oct 13;11(1):5145. doi: 10.1038/s41467-020-18885-9. |
| 21917874 | Derived | Moragianni VA, Aronis KN, Chamberland JP, Mantzoros CS. Short-term energy deprivation alters activin a and follistatin but not inhibin B levels of lean healthy women in a leptin-independent manner. J Clin Endocrinol Metab. 2011 Dec;96(12):3750-8. doi: 10.1210/jc.2011-1453. Epub 2011 Sep 14. |
| 21660636 | Derived | Aronis KN, Diakopoulos KN, Fiorenza CG, Chamberland JP, Mantzoros CS. Leptin administered in physiological or pharmacological doses does not regulate circulating angiogenesis factors in humans. Diabetologia. 2011 Sep;54(9):2358-67. doi: 10.1007/s00125-011-2201-x. Epub 2011 Jun 10. |
| 20703446 | Derived | Scheer FA, Chan JL, Fargnoli J, Chamberland J, Arampatzi K, Shea SA, Blackburn GL, Mantzoros CS. Day/night variations of high-molecular-weight adiponectin and lipocalin-2 in healthy men studied under fed and fasted conditions. Diabetologia. 2010 Nov;53(11):2401-5. doi: 10.1007/s00125-010-1869-7. Epub 2010 Aug 12. |
| Click here for more information about Beth Israel Deaconess Medical Center. | View source |
5 obese men were fasted for 72 hrs and during that period recieved 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit) |
| BG002 | OBESE WOMEN 24h Fed or 72h Fasting in Different Leptin Doses | 5 lean women were fasted for 72 hrs and during that period received 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Primary | Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg | 72-hour fasting Day 3 Leptin dose 0.01 mg/kg | Posted | Mean | Standard Deviation | NG/ML | 3 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg | 72-hour fasting Day 3 Leptin dose 0.01 mg/kg | Posted | Mean | Standard Deviation | NG*H/ML | 3 DAY |
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| Primary | Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg | 72-hour fasting Day 3 Leptin dose 0.1 mg/kg | Posted | Mean | Standard Deviation | HR | 3 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg | 72-hour fasting Day 3 Leptin dose 0.1 mg/kg | Posted | Mean | Standard Deviation | NG/ML | 3 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg | 72-hour fasting Day 3 Leptin dose 0.1 mg/kg | Posted | Mean | Standard Deviation | NG*H/ML | 3 DAY |
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| Primary | Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg | 72-hour fasting Day 3 Leptin dose 0.3 mg/kg | Posted | Mean | Standard Deviation | HR | 3 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg | 72-hour fasting Day 3 Leptin dose 0.3 mg/kg | Posted | Mean | Standard Deviation | NG/ML | 3 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg | 72-hour fasting Day 3 Leptin dose 0.3 mg/kg | Posted | Mean | Standard Deviation | NG*H/ML | 3 DAY |
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| Primary | Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg | 24-hour fed Leptin dose 0.3 mg/kg | Posted | Mean | Standard Deviation | HR | 1 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg | 24-hour fed Leptin dose 0.3 mg/kg | Posted | Mean | Standard Deviation | NG/ML | 1 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg | 24-hour fed Leptin dose 0.3 mg/kg | Posted | Mean | Standard Deviation | NG*H/ML | 1 DAY |
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| Primary | Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg | 24-hour fed Leptin dose 0.01 mg/kg | Posted | Mean | Standard Deviation | HR | 1 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg | 24-hour fed Leptin dose 0.01 mg/kg | Posted | Mean | Standard Deviation | NG/ML | 1 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg | 24-hour fed Leptin dose 0.01 mg/kg | Posted | Mean | Standard Deviation | NG*H/ML | 1 DAY |
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| Primary | Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg | 24-hour fed Leptin dose 0.1 mg/kg | Posted | Mean | Standard Deviation | HR | 1 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg | 24-hour fed Leptin dose 0.1 mg/kg | Posted | Mean | Standard Deviation | NG/ML | 1 DAY |
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| Primary | Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg | 24-hour fed Leptin dose 0.1 mg/kg | Posted | Mean | Standard Deviation | NG*H/ML | 1 DAY |
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| Secondary | Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) | Data were collected neither in Fed nor in Fasting state for the different doses of leptin | Posted | 1 DAY or DAY 3 |
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| Secondary | Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) | Data were collected neither in Fed nor in Fasting state for the different doses of leptin | Posted | 1 DAY or DAY 3 |
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| Secondary | Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) | Data were collected neither in Fed nor in Fasting state for the different doses of leptin | Posted | day 3 of fasting and day 1 of fed state |
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| 0 |
| 15 |
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| 15 |
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