Phase II clinical trial of combination therapy with medium-chain triglycerides and ghrelin in patients with chronic obstructive pulmonary disease

Phase 2

• Conditions: COPD

• Registration Number: JPRN-UMIN000015222
• Lead Sponsor: ational Hospital Organization Toneyama National Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-01
• Study Completion: 2021-09-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with malignant tumors 2) Patients with active infection 3) Patients with severe heart disease 4) Patients with hepatic failure (serum levels of AST and ALT greater than twice the normal upper limits) 5) Patients with renal failure (serum creatinine concentration >= 2.0 mg/dL) 6) Patients with asthma or who tested positive on an airway reversibility test 7) Patients who are or could be pregnant 8) Patients who are undergoing diabetes mellitus therapy or whose HbA1C>7.0 9) Patients whose drug regimen was changed within one month before participation in this study 10) In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Peak oxygen uptake 2) SGRQ score

Secondary Outcome Measures

Name	Time	Method
1) Plasma VEGF level 2) O2-pulse 3) VD/VT 4) VE/Vo2 5) VE/Vco2 6) Respiratory muscle strength 7) Plasma norepinephrine level 8) Body weight 9) CAT score 10) MRC dyspnea scale 11) Six-minute walk distance 12) Food intake 13) Circadian change of plasma active ghrelin level 14) Fatty acids fraction 15) Time course of serum growth hormone level