Effects of 5-Aminolevulinic Acid on Glucose Metabolism

Not Applicable

Completed

• Conditions: Type 2 Diabetes on Medication
• Interventions: Dietary Supplement: 5-aminolevulinic acid phosphate; Dietary Supplement: Placebo

• Registration Number: NCT01610778
• Lead Sponsor: Hiroshima University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplement	5-aminolevulinic acid phosphate	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Fasting glucose level	Every 4 weeks (Overall 36 weeks)
HbA1c level	Every 4 weeks (Overall 36 weeks)
Glycoalbumin level	Every 4 weeks (Overall 36 weeks)

Secondary Outcome Measures

Name	Time	Method
Fasting insulin level	Every 4 weeks (Overall 36 weeks)
1,5-AG level	Every 4 weeks (Overall 36 weeks)
Serum C-peptide level	Every 4 weeks (Overall 36 weeks)
HOMA-R	Every 4 weeks (Overall 36 weeks)

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima, Japan