Trial Outcomes & Findings for Growth Hormone as a Determinant of Weight Regulation (NCT NCT00355784)

NCT ID: NCT00355784

Last Updated: 2016-01-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2016-01-01

Participant Flow

All subjects were admitted to the Michigan Clinical Research Unit at the University of Michigan Hospital. Subjects were recruited from February 2006-February 2011.

Before the overeating intervention all subjects were admitted to the hospital for a 2-day experiment to assess their plasma growth hormone and insulin profiles.

Participant milestones

Measure	Control 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Overall Study STARTED	9	8	7
Overall Study COMPLETED	9	8	5
Overall Study NOT COMPLETED	0	0	2

Reasons for withdrawal

Measure	Control 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Overall Study Withdrawal by Subject	0	0	2

Baseline Characteristics

Growth Hormone as a Determinant of Weight Regulation

Baseline characteristics by cohort

Measure	Control n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone.	Total n=22 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	9 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	22 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	24.5 years STANDARD_DEVIATION 1.2 • n=5 Participants	23.1 years STANDARD_DEVIATION 1.0 • n=7 Participants	24.9 years STANDARD_DEVIATION 1.9 • n=5 Participants	24.4 years STANDARD_DEVIATION 0.8 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	5 participants n=5 Participants	22 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: per protocol

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
24 Hour Average Plasma Growth Hormone Concentration	0.4 ng/mL Standard Error 0.1	1.2 ng/mL Standard Error 0.1	4.1 ng/mL Standard Error 0.3

PRIMARY outcome

Timeframe: 2 weeks

Population: per protocol

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Changes in Body Weight	2.4 kg Standard Error 0.6	3.6 kg Standard Error 0.6	3.1 kg Standard Error 0.7

PRIMARY outcome

Timeframe: baseline

Population: per protocol

Whole body proteolytic rate (Leucine Ra)

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Baseline Whole Body Protein Turnover	2.1 μmol/kg fat free mass/min) Standard Error 0.1	1.9 μmol/kg fat free mass/min) Standard Error 0.1	1.6 μmol/kg fat free mass/min) Standard Error 0.1

PRIMARY outcome

Timeframe: baseline

Population: per protocol

after an overnight fast

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Baseline Skeletal Muscle Protein Synthesis	0.043 skeletal muscle protein%/hour Standard Error 0.009	0.047 skeletal muscle protein%/hour Standard Error 0.011	0.033 skeletal muscle protein%/hour Standard Error 0.006

PRIMARY outcome

Timeframe: 2 weeks

Population: per protocol

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Lipolytic Rate	180 µmol/min Standard Error 19	200 µmol/min Standard Error 20	195 µmol/min Standard Error 25

PRIMARY outcome

Timeframe: 2 weeks

Population: per protocol

whole body proteolytic rate (leucine Ra)

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Whole Body Protein Turnover After 2 Week Intervention	2.8 µmol/kg fat free mass/min Standard Error 0.2	2.3 µmol/kg fat free mass/min Standard Error 0.1	1.9 µmol/kg fat free mass/min Standard Error 0.1

PRIMARY outcome

Timeframe: 2 weeks

Population: per protocol

after an overnight fast

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
2 Week Skeletal Muscle Protein Synthesis	0.063 skeletal muscle protein%/hour Standard Error 0.015	0.062 skeletal muscle protein%/hour Standard Error 0.018	0.082 skeletal muscle protein%/hour Standard Error 0.011

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Changes in Fat Mass	1.6 kg Standard Error 0.3	1.7 kg Standard Error 0.2	1.1 kg Standard Error 0.3

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Control (CON) n=9 Participants 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 Participants 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 Participants 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Changes in Fat-free Mass	0.7 kg Standard Error 0.3	2.2 kg Standard Error 0.3	2.3 kg Standard Error 0.6

Adverse Events

Control (CON)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Growth Hormone Treatment (GHT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Growth Hormone Treatment (High-GHT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control (CON) n=9 participants at risk 9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.	Growth Hormone Treatment (GHT) n=8 participants at risk 8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.	High Growth Hormone Treatment (High-GHT) n=5 participants at risk 5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity \</- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate \~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1	0.00% 0/8	0.00% 0/5

Additional Information

Jeffrey F. Horowitz

University of Michigan, Ann Arbor, Michigan

Phone: 734-647-1076

Email: jeffhoro@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place