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Effects of 5-Aminolevulinic Acid on Glucose Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01610778
First Posted: June 4, 2012
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SBI Pharmaceuticals Co, Ltd.
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Fumiko Higashikawa, Hiroshima University:

Primary Outcome Measures:
  • Fasting glucose level [ Time Frame: Every 4 weeks (Overall 36 weeks) ]
  • HbA1c level [ Time Frame: Every 4 weeks (Overall 36 weeks) ]
  • Glycoalbumin level [ Time Frame: Every 4 weeks (Overall 36 weeks) ]

Secondary Outcome Measures:
  • Fasting insulin level [ Time Frame: Every 4 weeks (Overall 36 weeks) ]
  • 1,5-AG level [ Time Frame: Every 4 weeks (Overall 36 weeks) ]
  • Serum C-peptide level [ Time Frame: Every 4 weeks (Overall 36 weeks) ]
  • HOMA-R [ Time Frame: Every 4 weeks (Overall 36 weeks) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610778


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

Responsible Party: Fumiko Higashikawa, Associate professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01610778     History of Changes
Other Study ID Numbers: eki-541
First Submitted: May 31, 2012
First Posted: June 4, 2012
Last Update Posted: December 19, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents