Effects of 5-Aminolevulinic Acid on Glucose Metabolism

December 17, 2013 updated by: Fumiko Higashikawa, Hiroshima University

A Randomized, Double-blind, Cross-over Study to Assess Efficacy of 5-Aminolevulinic Acid in Type 2 Diabetic Patients on Medication.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 7320814
        • Hiroshima University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Experimental: Supplement
Dietary supplement: 5-aminolevulinic acid phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting glucose level
Time Frame: Every 4 weeks (Overall 36 weeks)
Every 4 weeks (Overall 36 weeks)
HbA1c level
Time Frame: Every 4 weeks (Overall 36 weeks)
Every 4 weeks (Overall 36 weeks)
Glycoalbumin level
Time Frame: Every 4 weeks (Overall 36 weeks)
Every 4 weeks (Overall 36 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hiroshima University

Collaborators

SBI Pharmaceuticals Co, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eki-541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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