Effects of 5-Aminolevulinic Acid on Glucose Metabolism

Hiroshima University

Status: Completed

Conditions: Type 2 Diabetes on Medication

Treatments: Dietary Supplement: 5-aminolevulinic acid phosphate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01610778

eki-541

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Supplement

Experimental group

Treatment:

Dietary Supplement: 5-aminolevulinic acid phosphate