COPD
Conditions
Interventions
1) Administration of edible oil consisting of medium-chain C8 triglyceride (octanoic acid) <
5 g of edible oil consisting of medium-chain C8 triglyceride will be administered orally, twice daily, for 26 days (at breakfast and at lunch). 2) Administration of ghrelin <
The administration schedule of synthetic human ghrelin>
5-day treatment with medium-chain triglyceride (MCT) followed by 3-week combination treatment with MCT and synthetic human ghrelin will be performed. Synthetic human ghrelin (2 micro-gram/kg, dissolve
Sponsors
National Hospital Organization Toneyama National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with sever to very severe COPD (FEV1% < 70%, and %FEV1 < 50%) 2) Underweight patients (BMI < 21 kg/m2) 3) Patients whose conditions are stable and who are able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation 4) Patients who have signed the agreement for participation in this study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Peak oxygen uptake 2) SGRQ score | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKeisuke Miki
National Hospital Organization Toneyama National Hospital Laboratory Chief, Laboratory of Respiratory Science, Division of Clinical Research
Outcome results
None listed