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Effects of 5-Aminolevulinic Acid on Glucose Metabolism

This study has been completed.
Sponsor:
Collaborator:
SBI Pharmaceuticals Co, Ltd.
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
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) ]
  • 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
  More Information

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

Additional relevant MeSH terms:
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on March 27, 2017