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OpenTrials
Completed

NCT Number: NCT01610778

Effects of 5-Aminolevulinic Acid on Glucose Metabolism

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

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Key information

Conditions

Type 2 Diabetes on Medication

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 7320814, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

5-aminolevulinic acid phosphate

Dietary Supplement

Primary outcomes

  1. Fasting glucose level

    Time frame: Every 4 weeks (Overall 36 weeks)

  2. HbA1c level

    Time frame: Every 4 weeks (Overall 36 weeks)

  3. Glycoalbumin level

    Time frame: Every 4 weeks (Overall 36 weeks)

Secondary outcomes

  1. Fasting insulin level

    Time frame: Every 4 weeks (Overall 36 weeks)

  2. 1,5-AG level

    Time frame: Every 4 weeks (Overall 36 weeks)

  3. Serum C-peptide level

    Time frame: Every 4 weeks (Overall 36 weeks)

  4. HOMA-R

    Time frame: Every 4 weeks (Overall 36 weeks)

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • SBI Pharmaceuticals Co, Ltd.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 4, 2012
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.