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

NCT01206582 | Completed Phase 2 Results

• 3 other identifiers: 09-000129P01DK068055UL1TR000135
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastroparesis; Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Venous Plasma Heme-oxygenase 1 (HO1) Protein Concentration

  HO1 protein concentration levels in plasma were assessed with a HO1 (human) enzyme-linked immunosorbent assay (ELISA) kit.

  baseline, day 3, day 7, day 56

• Venous Monocyte HO1 Activity

  HO1 activity in white blood cells was measured by an assay that measures bilirubin production as a marker of HO1 activity.

  baseline, Day 3, Day 7, Day 56

• Gastric Emptying Half-time

  The time for half of the ingested solids or liquids to leave the stomach. Gastric emptying was assessed with \^13C Spirulina Breath Test. After an overnight fast, subjects consumed the test meal containing \^13C Spirulina. Breath samples were collected in duplicate glass tube using a straw to blow into the bottom of the tube to displace contained air. The \^13CO\_2 content of the breath was determined by AB Diagnostics. The provide of \^13CO\_2 excretion is used to estimate the half-time of gastric emptying.

  baseline, day 3, day 7, day 56

Secondary Outcomes (8)

• Gastrointestinal Symptoms

  baseline, 8 weeks

• Autonomic Functions

  baseline, Day 56

• Serum Creatinine

  baseline, Day 4, Day 7, Day 56

• Prothrombin Time

  baseline, Day 4, Day 7, Day 56

• Activated Partial Thromboplastin Time (APTT)

  baseline, Day 4, Day 7, Day 56

Study Arms (2)

Hemin

ACTIVE COMPARATOR

Panhematin®, Ovation Pharmaceuticals, Deerfield, Illinois (IL). Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks

Biological: Hemin

Albumin

PLACEBO COMPARATOR

10 iv infusions for 8 weeks

Biological: Albumin

Interventions

Hemin BIOLOGICAL

10 iv infusions for 8 weeks

Also known as: Panhematin®, (Ovation Pharmaceuticals, Deerfield, IL)

Hemin

Albumin BIOLOGICAL

10 iv infusions for 8 weeks

Also known as: Albumin (Human) 25% Solution manufactured by CSL Behring.

Albumin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Upper gastrointestinal symptoms which satisfy criteria for postprandial distress syndrome or vomiting for the last 3 months with symptom onset at least 6 months prior to diagnosis
• At least moderately severe symptoms as manifest by a total symptom score of 2.5 or higher on the Gastroparesis Cardinal Symptom Index (GCSI)21
• Delayed gastric emptying (i.e, \< 40% emptying at 2 and/or \< 90% emptying at 4 hours by scintigraphy)
• No structural cause for symptoms by endoscopy within the past 12 months
• Patient must have a platelet counts \> 50,000/microliters and absolute neutrophil counts (ANC) \>500/microliters.
• Patient must have adequate hepatic and renal functions, defined as serum bilirubin, serum glutamic-oxaloacetic transaminase (SGOT), and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times the upper limit of normal (ULN), and creatinine ≤ 1.5 times the ULN.
• Able to provide written informed consent before participating in the study
• If female:
• Either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if of childbearing potential, must comply with an effective method of birth control acceptable to the investigator during the study (oral contraceptives, Depo-Provera, intra-uterine device or barrier methods)
• Patient is not breastfeeding.
• Patient of childbearing potential must have a negative urine or serum pregnancy test during the screening period.
• History of allergic reaction or significant sensitivity to Panhemantin ®
• Patients who have taken or used any investigational drug or device in the 30 days prior to screening
• Predominant symptoms of epigastric pain or rumination syndrome
• Structural cause for symptoms on recent endoscopy

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• RECORDATI GROUP: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus

Interventions

Hemin; Albumins

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heme; Metalloporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Adil E. Bharucha
• Organization: Mayo Clinic

bharucha.adil@mayo.edu

507-284-6439

Study Officials

• Adil E Bharucha, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 22, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-01

Locations

US (1)