CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
growth hormone treatment +1 moredrug
Likely dose
Growth hormone 1.0 mg/m²/day for 2 weeksAI-extracted
Key inclusion· 5
  • Age 21–35 years
  • Weight stable (±5 pounds over past 6 months)
  • BMI 18–26 kg/m²
  • Premenopausal (women only)
Key exclusion· 8
  • Evidence of metabolic disease
  • Evidence of cardiovascular disease
  • Pregnancy (women only)
  • Hyperlipidemia (fasting triglycerides >150 mg/dL)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00355784
NCT00355784N/ACompleted

Growth Hormone as a Determinant of Weight Regulation.

University of Michigan·interventional·Posted Jul 25, 2006·Updated Jan 1, 2016

In Brief

A clinical study evaluating overfeeding and growth hormone treatment for Obesity. Completed, enrolled 24 participants across 1 site.

Detailed Summary

With the alarming increase in the prevalence of obesity, identifying factors that predispose individuals to weight-gain is of critical importance. Even when caloric intake and physical activity levels are well controlled, susceptibility for weight-gain is heterogeneous. Basal metabolic rate (BMR) represents the largest portion of daily energy expenditure in normal adults, and as such, variability in BMR among individuals can be a major factor in determining the susceptibility for gaining weight. However, factors responsible for this variability in BMR and resistance to weight-gain remain unclear. Our preliminary data indicate that high-normal growth hormone (GH) concentration is associated with resistance to weight-gain in rats when overfed and greater weight-loss in humans when underfed. In addition, the investigators have found that the pulsatility of GH secretion has profound effects on several metabolic processes. Therefore, together these findings suggest that endogenous GH secretion is associated with body weight regulation, and the pulsatility (peak amplitude) of GH secretion, rather than the absolute GH concentration, per se, may be responsible for this effect. Because GH influences many of the key metabolic processes that contribute to BMR (e.g.; protein synthesis, proteolysis, substrate cycling), the investigators anticipate that the resistance to weight-gain in persons with elevated GH concentrations will be associated with an increase in BMR due to acceleration of some or all of these processes. Our overall hypothesis is that increased GH secretion can protect against weight-gain due to an augmentation of major metabolic processes that contribute to BMR. Identifying factors responsible for predisposing individuals to weight-gain will lead to establishing improved methods for reducing the prevalence of obesity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2006
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2011
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 19.9 years ago

Interventions

overfeedingother

overfeeding 2000kcals/day above energy requirements for 14d

growth hormone treatmentdrug

growth hormone administrated for 2 weeks (dose = 1.0 mg/m2/d)