NCT01206582

A Pilot Study of Hemin Therapy for Gastroparesis (Diabetes Mellitus)

A Pilot Study of Hemin Therapy for Gastroparesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to learn if hemin can increase the production of heme oxygenase 1 and improve gastric (stomach) emptying and symptoms in diabetic patients with slow gastric emptying (gastroparesis).

Detailed description

Therapeutic options for management of diabetic gastroparesis are limited. Failure to maintain upregulation of heme oxygenase 1 (HO1) leads to loss of interstitial cells of Cajal and delayed gastric emptying in diabetic non-obese diabetic mice. HO1 is an enzyme which protects cells from physical, chemical, and biologic stress. In mice with diabetes and slow gastric emptying, hemin increases HO-1 activity and improves gastric emptying. Hemin is produced from red blood cells and is approved by the Food and Drug Administration for treating acute porphyria, which is an inherited condition caused by an enzyme deficiency. Hemin is not approved by the Food and Drug Administration for treating gastroparesis. In this study subjects were randomized to intravenous hemin, prepared in albumin, or albumin alone. After infusions on days 1, 3, and 7, weekly infusions were administered for 7 weeks. Assessments included blood tests for HO1 protein and enzyme activity levels, gastric emptying with 13\^C-spirulina breath test, autonomic functions (baseline and end), and gastrointestinal symptoms every 2 weeks.

Conditions

• Gastroparesis
• Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Hemin	10 iv infusions for 8 weeks
BIOLOGICAL	Albumin	10 iv infusions for 8 weeks

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-09-22
• Last updated: 2016-02-04
• Results posted: 2016-02-04

Locations

1 site across 1 country: United States