Trial Outcomes & Findings for Recombinant Human Leptin Therapy Effects on Insulin Action (NCT NCT01207934)

Results Overview

pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

baseline

Results posted on

2015-07-09

Participant Flow

Subjects were recruited from August 1998 to August 1999. All subjects were recruited via the Volunteer for Health system at Washington University School of Medicine.

Participant milestones

Participant milestones
Measure	Placebo saline placebo for fourteen days	Low-dose Leptin 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days	High-dose Leptin 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
Overall Study STARTED	6	6	6
Overall Study COMPLETED	6	6	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recombinant Human Leptin Therapy Effects on Insulin Action

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6 Participants saline placebo for fourteen days	Low-dose Leptin n=6 Participants 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days	High-dose Leptin n=6 Participants 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	60 years STANDARD_DEVIATION 1.2 • n=5 Participants	53 years STANDARD_DEVIATION 2.9 • n=7 Participants	54 years STANDARD_DEVIATION 1.6 • n=5 Participants	56 years STANDARD_DEVIATION 1.9 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	18 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline

pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants 14 days on placebo (saline)	Low Dose Leptin n=6 Participants 30mg leptin daily for fourteen days	High Dose Leptin n=6 Participants 80mg leptin daily for fourteen days
Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.	14.3 mmol/kg body weight/minute Standard Error 3.1	18.4 mmol/kg body weight/minute Standard Error 3.6	16.7 mmol/kg body weight/minute Standard Error 2.4

PRIMARY outcome

Timeframe: fourteen days

This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants 14 days on placebo (saline)	Low Dose Leptin n=6 Participants 30mg leptin daily for fourteen days	High Dose Leptin n=6 Participants 80mg leptin daily for fourteen days
Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.	17.5 mmol/kg body weight/minute Standard Error 2.5	20.7 mmol/kg body weight/minute Standard Error 3.0	19.1 mmol/kg body weight/minute Standard Error 3.3

SECONDARY outcome

Timeframe: baseline

Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants 14 days on placebo (saline)	Low Dose Leptin n=6 Participants 30mg leptin daily for fourteen days	High Dose Leptin n=6 Participants 80mg leptin daily for fourteen days
Baseline Plasma Leptin Concentrations	27 Micrograms/Liter Standard Error 7	24 Micrograms/Liter Standard Error 8	35 Micrograms/Liter Standard Error 10

SECONDARY outcome

Timeframe: fourteen days

plasma leptin levels after fourteen days ingestion of either leptin or placebo.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants 14 days on placebo (saline)	Low Dose Leptin n=6 Participants 30mg leptin daily for fourteen days	High Dose Leptin n=6 Participants 80mg leptin daily for fourteen days
Post-treatment Plasma Leptin Levels	25 Micrograms/Liter Standard Error 5	76 Micrograms/Liter Standard Error 19	5024 Micrograms/Liter Standard Error 500

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low-dose Leptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High-dose Leptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samuel Klein, MD

Washington University School of Medicine

Phone: 3143628708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place