CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 144 enrolled
Drug / intervention
Rapamycin +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00891696
NCT00891696Phase 1Completed

Nutritional and Contractile Regulation of Muscle Growth (Cycle 2)

The University of Texas Medical Branch, Galveston·interventional·Posted May 1, 2009·Updated May 4, 2017

In Brief

A Phase 1 clinical trial evaluating Rapamycin, Amino acid supplementation, and 3 other interventions for Sarcopenia. Completed, enrolled 144 participants across 1 site.

Detailed Summary

Muscle wasting, which involves the loss of muscle tissue, is common in many conditions, such as cancer, AIDS, trauma, kidney failure, bone fracture, and sepsis. It is also prevalent among the elderly and in people who experience periods of physical inactivity and weightlessness. Muscle wasting can lead to overall weakness, immobility, physical dependence, and a greater risk of death when exposed to infection, surgery, or trauma. There is a need to develop scientifically based treatments that prevent muscle wasting. As one step towards such a goal, this study will examine the physiological and cellular mechanisms that regulate skeletal muscle growth.

Study Details

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

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2009
Enrollment StartApr 1, 2009
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 17.2 years ago

Interventions

Rapamycindrug

Single 16-mg oral dose

Amino acid supplementationother

Nutritional drink containing essential amino acids

Low-intensity resistance exerciseother

Leg extension exercises on a Cybex leg extension machine

Sodium nitroprussidedrug

Variable rate for 3 hours

Blood flow restriction cuffdevice

Blood flow restriction for 5 minutes after the second biopsy

Low-intensity resistance exerciseother

Leg extension exercises on a Cybex leg extension machine