Double-blind randomized cross-over trial to assess the efficacy and safety of subcutaneous ghrelin in diabetic patients with cardiac autonomic dysfunction

Double-blind randomized cross-over trial to assess the efficacy and safety of subcutaneous ghrelin in diabetic patients with cardiac autonomic dysfunction - Effect of subcutaneous ghrelin on diabetic autonomic neuropathy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008386

Enrollment

Registered

2012-07-09

Start date

2012-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

Subcutaneous ghrelin injection Subcutaneous placebo injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus with 1. age of 40 years old or over 2. systolic blood pressure of 110 mmHg or over 3. resting heart rate of 60 bpm or over 4. compliance to dietary restriction 5. written informed consent

Exclusion criteria

Exclusion criteria: 1. recent acute cardiovascular or cerebrovascular event 2. severe cardiac dysfunction 3. severe pulmonary dysfunction 4. active hepatitis or cirrhosis 5. severe kidney dysfuntion 6. severely impaired glucose control 7. untreated retinopathy 8. active infection 9. pregnancy 10. severe neuropathy 11. malignancy 12. severe arrhythmia 13. other reasons decided by physician

Design outcomes

Primary

Measure	Time frame
1. Safety 2. Changes in autonomic function indices by heart rate variability using power spectrum analysis	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026