Effects of 5-Aminolevulinic Acid on Glucose Metabolism

This study has been completed.
Sponsor:
Collaborator:
SBI Pharmaceuticals Co., Ltd., Japan
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
ClinicalTrials.gov Identifier:
NCT01610778
First received: May 31, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2 diabetes on medication.


Condition Intervention
Type 2 Diabetes on Medication
Dietary Supplement: Placebo
Dietary Supplement: 5-aminolevulinic acid phosphate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Cross-over Study to Assess Efficacy of 5-Aminolevulinic Acid in Type 2 Diabetic Patients on Medication.

Resource links provided by NLM:


Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Fasting glucose level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • HbA1c level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • Glycoalbumin level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting insulin level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • 1,5-AG level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • Serum C-peptide level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • HOMA-R [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Placebo
Experimental: Supplement Dietary Supplement: 5-aminolevulinic acid phosphate

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients on medication
  • HbA1c ≤ 9.0% (as JDS values, which is equivalent to HbA1c ≤ 9.4% as NGSP values)
  • On stable treatment of diabetes for at least the last 3 months
  • With permission to attend the clinical trial from the primary doctor

Exclusion Criteria:

  • On insulin therapy
  • BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
  • History of porphyria, hemochromatosis, or viral hepatitis
  • Pregnant or nursing a child
  • Heart disease
  • Renal or hepatic dysfunction
  • Participation in any clinical trial within 90 days of the commencement of the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610778

Locations
Japan
Hiroshima University
Hiroshima, Japan, 7320814
Sponsors and Collaborators
Hiroshima University
SBI Pharmaceuticals Co., Ltd., Japan
  More Information

No publications provided

Responsible Party: Fumiko Higashikawa, Associate professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01610778     History of Changes
Other Study ID Numbers: eki-541
Study First Received: May 31, 2012
Last Updated: December 17, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014