Pharmacokinetics of Leptin Administration During Fasting

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00140205
• Collaborator: Amgen (Industry)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 190
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Energy Deficiency Due to Short-term Fasting	Drug: r-metHuLeptin	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pharmacokinetics of Leptin Administration During Fasting
• Study Start Date: Feb 1, 2001
• Actual Primary Completion Date: Jun 1, 2004
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fed state or fasting state 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	Drug: r-metHuLeptin; r-metreleptin was given in 3 different dose in fed and fasting states; Other Names: Recombinant leptin

Outcome Measures

Primary Outcome Measures

1. Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.01 mg/kg

2. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.01 mg/kg

3. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.01 mg/kg

4. Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.1 mg/kg

5. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.1 mg/kg

6. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.1 mg/kg

7. Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.3 mg/kg

8. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.3 mg/kg

9. Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg [3 DAY]

   72-hour fasting Day 3 Leptin dose 0.3 mg/kg

10. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.3 mg/kg

11. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.3 mg/kg

12. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.3 mg/kg

13. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.01 mg/kg

14. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.01 mg/kg

15. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.01 mg/kg

16. Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.1 mg/kg

17. Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.1 mg/kg

18. Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg [1 DAY]

    24-hour fed Leptin dose 0.1 mg/kg

Secondary Outcome Measures

1. Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) [1 DAY or DAY 3]

   Data were collected neither in Fed nor in Fasting state for the different doses of leptin

2. Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) [1 DAY or DAY 3]

   Data were collected neither in Fed nor in Fasting state for the different doses of leptin

3. Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg) [day 3 of fasting and day 1 of fed state]

   Data were collected neither in Fed nor in Fasting state for the different doses of leptin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy men with body mass indices (BMI) <25 kg/m2)

• overweight otherwise healthy men with BMI > 27 kg/m2

• healthy lean women with BMI<25 kg/m2

• overweight otherwise healthy women with BMI > 27 kg/m2

Exclusion Criteria:

• history of any illness that may affect the concentrations of the hormones that will be studied (such as anemia, infectious diseases, renal or hepatic failure, diabetes mellitus, cancer, lymphoma, hypogonadism, malabsorption or malnourishment, hypo or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)

• on medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti-seizure medications or thyroid hormones)

• known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E. Coli derived proteins

• women who are breast feeding, pregnant, or wanting to become pregnant during the next 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center
• Amgen

Investigators

• Principal Investigator: Christos S Mantzoros, MD DSc FACP FACE, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information about the Mantzoros Research Group.
• Click here for more information about Beth Israel Deaconess Medical Center.

Publications

None provided.

• Responsible Party: Christos Mantzoros, Professor of Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00140205
• Other Study ID Numbers: 2001P000260
• First Posted: Sep 1, 2005
• Last Update Posted: Nov 2, 2018
• Last Verified: May 1, 2017

• Keywords provided by Christos Mantzoros, Professor of Medicine, Beth Israel Deaconess Medical Center: leptin; fasting; pharmacokinetics

Study Results

Participant Flow

Arm/Group Title	5 LEAN MEN Fasting State (72 Hrs) on 0.3mg/kg Leptin	5 OBESE MEN 72 HR FASTING on 0.3mg/kg Leptin	5 LEAN WOMEN 72 HR FATSING on 0.3mg/kg Leptin
Arm/Group Description	5 lean men were fasted for 72 hrs and during that period recieved 0.3mg/kg leptin	5 obese men were fasted for 72 hrs and during that period received 0.3mg/kg leptin	5 lean women were fasted for 72 hrs and during that period received 0.3mg/kg leptin
Period Title: Overall Study
STARTED	5	5	5
COMPLETED	5	5	5
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	LEAN MEN 24h Fed or 72h Fasting in Different Leptin Doses	OBESE MEN 24h Fed or 72h Fasting in Different Leptin Doses	OBESE WOMEN 24h Fed or 72h Fasting in Different Leptin Doses	Total
Arm/Group Description	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)	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)	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)	Total of all reporting groups
Overall Participants	5	5	5	15
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	5 100%	5 100%	15 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (YEARS) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [YEARS]	22 (.09)	23 (.08)	22 (.05)	23 (.07)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	5 100%	5 33.3%
Male	5 100%	5 100%	0 0%	10 66.7%
Region of Enrollment (Count of Participants)
United States	5 100%	5 100%	5 100%	15 100%
BMI (participants) [Number]
BMI>30kg/m2	0 0%	5 100%	0 0%	5 33.3%
BMI<25kg/m2	5 100%	0 0%	5 100%	10 66.7%

Outcome Measures

1. Primary Outcome

Title	Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg	5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
Arm/Group Description
Measure Participants	5	5	5
TIME(T1/2) DAY 3	1.93 (0.28)	2.75 (1.49)	2.99 (1.01)
TMAX DAY 3	2.00 (0.71)	3.00 (0.71)	2.80 (1.30)

2. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting State (72 Hrs)	5 OBESE MEN 72 HR FASTING	5 LEAN WOMEN 72 HR FATSING
Arm/Group Description
Measure Participants	5	5	5
c(MAX)	2.60 (0.59)	4.21 (1.17)	4.62 (1.60)
L0 (ENDOGENOUS LEPTIN LEVEL)	1.42 (0.72)	3.32 (1.21)	3.53 (1.26)

3. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting State (72 Hrs)	5 OBESE MEN 72 HR FASTING	5 LEAN WOMEN 72 HR FATSING
Arm/Group Description
Measure Participants	5	5	5
Mean (Standard Deviation) [NG*H/ML]	12.27 (2.95)	35.43 (13.81)	47.81 (23.90)

4. Primary Outcome

Title	Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting (72 Hrs) - Leptin 0.1 mg/kg	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.1 mg/kg	5 LEAN WOMEN (72 Hrs) Fasting - Leptin 0.1 mg/kg
Arm/Group Description
Measure Participants	5	5	5
TIME(T1/2) DAY 3	1.82 (0.58)	3.10 (1.20)	1.73 (0.57)
TMAX DAY 3	3.20 (1.10)	4.00 (1.58)	3.00 (1.00)

5. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting State (72 Hrs) - Leptin 0.1 mg/kg	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.1 mg/kg	5 LEAN WOMEN Fasting (72 Hrs)- Leptin 0.1 mg/kg
Arm/Group Description
Measure Participants	5	5	5
c(MAX)	33.88 (9.38)	78.43 (14.71)	106.4 (36.7)
L0 (ENDOGENOUS LEPTIN LEVEL)	1.69 (0.89)	5.92 (1.33)	5.36 (1.89)

6. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting State (72 Hrs) - Leptin 0.1 mg/kg	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.1 mg/kg	5 LEAN WOMEN Fasting (72 Hrs)- Leptin 0.1 mg/kg
Arm/Group Description
Measure Participants	5	5	5
Mean (Standard Deviation) [NG*H/ML]	206.9 (56.9)	778.2 (121.5)	676.5 (267.4)

7. Primary Outcome

Title	Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting (72 Hrs) - Leptin 0.3 mg/kg	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.3 mg/kg	5 LEAN WOMEN Fasting (72 Hrs)- Leptin 0.3 mg/kg
Arm/Group Description
Measure Participants	5	5	5
TIME(T1/2) DAY 3	1.98 (0.28)	2.40 (0.54)	1.92 (0.45)
TMAX DAY 3	3.80 (1.30)	3.40 (1.67)	3.80 (1.48)

8. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting (72 Hrs) - Leptin 0.3 mg/kg	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.3 mg/kg	5 LEAN WOMEN Fasting (72 Hrs)- Leptin 0.3 mg/kg
Arm/Group Description
Measure Participants	5	5	5
c(MAX)	88.39 (32.13)	301.6 (86.8)	399.6 (76.8)
L0 (ENDOGENOUS LEPTIN LEVEL)	1.62 (0.64)	13.72 (2.97)	6.95 (1.05)

9. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
Description	72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Time Frame	3 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fasting (72 Hrs) - Leptin 0.3 mg/kg	5 OBESE MEN Fasting (72 Hrs) - Leptin 0.3 mg/kg	5 LEAN WOMEN Fasting (72 Hrs)- Leptin 0.3 mg/kg
Arm/Group Description
Measure Participants	5	5	5
Mean (Standard Deviation) [NG*H/ML]	747.3 (300.8)	2717 (647.1)	2738 (624)

10. Primary Outcome

Title	Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg
Description	24-hour fed Leptin dose 0.3 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.3 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.3 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.3 mg/kg
Arm/Group Description
Measure Participants	5	5	5
TIME(T1/2)	2.94 (0.95)	3.69 (1.13)	2.91 (0.90)
TMAX	3.60 (0.89)	3.40 (1.67)	2.80 (0.84)

11. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg
Description	24-hour fed Leptin dose 0.3 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.3 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.3 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.3 mg/kg
Arm/Group Description
Measure Participants	5	5	5
c(MAX)	168.7 (61.7)	254.3 (36.7)	440.7 (85.2)
L0 (ENDOGENOUS LEPTIN LEVEL)	2.97 (0.68)	16.24 (5.00)	12.60 (7.78)

12. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg
Description	24-hour fed Leptin dose 0.3 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.3 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.3 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.3 mg/kg
Arm/Group Description
Measure Participants	5	5	5
Mean (Standard Deviation) [NG*H/ML]	1243 (304.2)	2948 (521.9)	3300 (871)

13. Primary Outcome

Title	Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg
Description	24-hour fed Leptin dose 0.01 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.01 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.01 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.01 mg/kg
Arm/Group Description
Measure Participants	5	5	5
TIME(T1/2)	2.84 (0.98)	4.71 (2.16)	3.08 (1.24)
TMAX	3.00 (1.00)	6.20 (3.35)	2.80 (0.84)

14. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg
Description	24-hour fed Leptin dose 0.01 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.01 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.01 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.01 mg/kg
Arm/Group Description
Measure Participants	5	5	5
c(MAX)	5.97 (1.65)	7.91 (2.37)	14.51 (2.96)
L0 (ENDOGENOUS LEPTIN LEVEL)	2.32 (0.48)	12.67 (6.15)	15.54 (8.90)

15. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg
Description	24-hour fed Leptin dose 0.01 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.01 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.01 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.01 mg/kg
Arm/Group Description
Measure Participants	5	5	5
Mean (Standard Deviation) [NG*H/ML]	33.18 (8.68)	113.9 (56.6)	110.5 (45.0)

16. Primary Outcome

Title	Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg
Description	24-hour fed Leptin dose 0.1 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.1 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.1 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.1 mg/kg
Arm/Group Description
Measure Participants	5	5	5
TIME(T1/2)	2.89 (0.24)	4.72 (1.51)	2.08 (1.01)
TMAX	3.00 (1.58)	4.60 (0.89)	3.20 (0.84)

17. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg
Description	24-hour fed Leptin dose 0.1 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.1 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.1 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.1 mg/kg
Arm/Group Description
Measure Participants	5	5	5
c(MAX)	72.56 (12.19)	77.26 (10.10)	107.4 (19.4)
L0 (ENDOGENOUS LEPTIN LEVEL)	2.11 (0.50)	15.49 (8.64)	14.36 (11.12)

18. Primary Outcome

Title	Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg
Description	24-hour fed Leptin dose 0.1 mg/kg
Time Frame	1 DAY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24 Hrs) - Leptin 0.1 mg/kg	5 OBESE MEN Fed (24 Hrs) - Leptin 0.1 mg/kg	5 LEAN WOMEN Fed (24 Hrs) - Leptin 0.1 mg/kg
Arm/Group Description
Measure Participants	5	5	5
Mean (Standard Deviation) [NG*H/ML]	507.4 (44.1)	1051 (202.9)	620.2 (157.1)

19. Secondary Outcome

Title	Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
Description	Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Time Frame	1 DAY or DAY 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24h) or Fasting (72 Hrs)	5 OBESE MEN Fed (24h) or Fasting (72 Hrs)	5 LEAN WOMEN Fed (24h) or Fasting (72 Hrs)
Arm/Group Description
Measure Participants	0	0	0

20. Secondary Outcome

Title	Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
Description	Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Time Frame	1 DAY or DAY 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24h) or Fasting (72 Hrs)	5 OBESE MEN Fed (24h) or Fasting (72 Hrs)	5 LEAN WOMEN Fed (24h) or Fasting (72 Hrs)
Arm/Group Description
Measure Participants	0	0	0

21. Secondary Outcome

Title	Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)
Description	Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Time Frame	day 3 of fasting and day 1 of fed state

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 LEAN MEN Fed (24h) or Fasting (72 Hrs)	5 OBESE MEN Fed (24h) or Fasting (72 Hrs)	5 LEAN WOMEN Fed (24h) or Fasting (72 Hrs)
Arm/Group Description
Measure Participants	0	0	0

Adverse Events

Arm/Group Title	Fasting State (72 Hrs)
Arm/Group Description
All Cause Mortality
	Fasting State (72 Hrs)
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	Fasting State (72 Hrs)
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Fasting State (72 Hrs)
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

small size population, results cannot be generalized

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.