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A single-arm, open-label, intervention study to investigate the improvement of glucose tolerance after administration of the 5-aminolevulinic acid (5-ALA) in the patients with mitochondrial diabetes mellitus.
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- Author(s): Nakamura Y;Nakamura Y;Nakamura Y; Haraguchi A; Haraguchi A; Haraguchi A; Shigeno R; Shigeno R; Shigeno R; Ito A; Ito A; Ito A; Horie I; Horie I; Horie I; Kawakami A; Kawakami A; Kawakami A; Abiru N; Abiru N; Abiru N
- Source:
Medicine [Medicine (Baltimore)] 2021 Mar 12; Vol. 100 (10), pp. e25100.- Publication Type:
Clinical Trial Protocol; Journal Article- Language:
English - Source:
- Additional Information
- Source: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 2985248R Publication Model: Print Cited Medium: Internet ISSN: 1536-5964 (Electronic) Linking ISSN: 00257974 NLM ISO Abbreviation: Medicine (Baltimore) Subsets: MEDLINE
- Publication Information: Original Publication: Hagerstown, Md : Lippincott Williams & Wilkins
- Subject Terms: Deafness/*drug therapy ; Diabetes Mellitus, Type 2/*drug therapy ; Ferrous Compounds/*administration & dosage ; Glucose Intolerance/*drug therapy ; Insulin/*administration & dosage ; Levulinic Acids/*administration & dosage ; Mitochondrial Diseases/*drug therapy; Adenosine Triphosphate/metabolism ; Adult ; Blood Glucose/analysis ; Citric Acid ; Deafness/blood ; Deafness/diagnosis ; Deafness/pathology ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/pathology ; Drug Therapy, Combination/adverse effects ; Drug Therapy, Combination/methods ; Female ; Ferrous Compounds/adverse effects ; Glucose Intolerance/blood ; Glucose Intolerance/diagnosis ; Glucose Intolerance/pathology ; Glucose Tolerance Test ; Humans ; Japan ; Levulinic Acids/adverse effects ; Male ; Mitochondria/drug effects ; Mitochondria/pathology ; Mitochondrial Diseases/blood ; Mitochondrial Diseases/diagnosis ; Mitochondrial Diseases/pathology ; Pilot Projects ; Treatment Outcome ; Aminolevulinic Acid
- Abstract: Background: Mitochondrial diabetes mellitus (MDM) is characterized by maternal inheritance, progressive neurosensory deafness, insulin secretory disorder, and progressive microvascular complications. Mitochondria are critical organelles that provide energy in the form of adenosine triphosphate (ATP). An impairment of ATP production in pancreatic β cells is regarded as the main cause of the insulin secretory disorder in patients with MDM, and these patients require insulin replacement therapy early after the diagnosis. The amino acid 5-aminolevulinic acid (5-ALA), a precursor of heme metabolites, is a non-proteinogenic δ amino acid synthesized in mitochondria. An addition of ferrous iron to 5-ALA enhances heme biosynthesis and increases ATP production through an upregulation of the respiratory complex. Several studies have reported that the administration of 5-ALA and ferrous iron to existing treatment improved the glycemic control in both patients with prediabetes and those with type 2 diabetes mellitus. The additional administration of 5-ALA and ferrous iron to MDM patients on insulin therapy may improve their insulin secretory capacity and glycemic control by improving their mitochondrial function. The findings of this study are expected to provide new treatment options for MDM and improve the patients' glycemic control and prognosis.
Methods/design: This study is a single-arm, open-label pilot intervention study using clinical endpoints to investigate the effects of treatment with 5-ALA plus sodium ferrous citrate (SFC) to patients with MDM on their glucose tolerance. A total of 5 patients with MDM will be administered 5-ALA/SFC (200 mg/d) for 24 weeks. We will perform a 75-g oral glucose tolerance test before and at 24 weeks after the start of this 5-ALA/SFC treatment to evaluate glucose-dependent insulin responses.
Discussion: To the best of our knowledge, this study will be the first assessment of the effects of 5-ALA/SFC in patients with MDM. This study will obtain an evidence regarding the effectiveness and safety of 5-ALA/SFC for patients with MDM.
Trial Registration: This study was registered with the University Hospital Medical Information Network (UMIN000040581) on July 1, 2020 and with the Japan Registry of Clinical Trials (jRCTs071200025) on August 3, 2020.
Competing Interests: The authors have no conflicts of interest to disclose.
(Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.) - References: Suzuki S, Oka Y, Kadowaki T, et al. Clinical features of diabetes mellitus with the mitochondrial DNA 3243 (A-G) mutation in Japanese: maternal inheritance and mitochondria-related complications. Diabetes Res Clin Pract 2003;59:207–17.
Kadowaki T, Kadowaki H, Mori Y, et al. A subtype of diabetes mellitus associated with a mutation of mitochondrial DNA. N Engl J Med 1994;330:962–8.
Fukuda M, Nakano S, Imaizumi N, et al. Mitochondrial DNA mutations are associated with both decreased insulin secretion and advanced microvascular complications in Japanese diabetic subjects. J Diabetes Complications 1999;13:277–83.
Guillausseau PJ, Massin P, Dubois-LaForgue D, et al. Maternally inherited diabetes and deafness: a multicenter study. Ann Intern Med 2001;134:721–8.
Kennedy ED, Maechler P, Wollheim CB. Effects of depletion of mitochondrial DNA in metabolism secretion coupling in INS-1 cells. Diabetes 1998;47:374–80.
Ogura S, Maruyama K, Hagiya Y, et al. The effect of 5-aminolevulinic acid on cytochrome c oxidase activity in mouse liver. BMC Res Notes 2011;4:66.
Rodriguez BL, Curb JD, Davis J, et al. Use of the dietary supplement 5-aminiolevulinic acid (5-ALA) and its relationship with glucose levels and hemoglobin A1C among individuals with prediabetes. Clin Transl Sci 2012;5:314–20.
Higashikawa F, Noda M, Awaya T, et al. 5-aminolevulinic acid, a precursor of heme, reduces both fasting and postprandial glucose levels in mildly hyperglycemic subjects. Nutrition 2013;29:1030–6.
Yamashita N, Watanabe A, Kondo H, et al. Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium ferrous citrate, in diabetic patients treated with oral hypoglycemic agents. Funct Food Health Dis 2014;4:415–28.
Al-Saber F, Aldosari W, Alselaiti M, et al. The safety and tolerability of 5-aminolevulinic acid phosphate with sodium ferrous citrate in patients with type 2 diabetes mellitus in Bahrain. J Diabetes Res 2016;2016:8294805.
Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7.
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310:2191–4.
Nishikawa T, Edelstein D, Du XL, et al. Normalizing mitochondrial superoxide production blocks three pathways of hyperglycaemic damage. Nature 2000;404:787–90.
Kukidome D, Nishikawa T, Sonoda K, et al. Activation of AMP-activated protein kinase reduces hyperglycemia-induced mitochondrial reactive oxygen species production and promotes mitochondrial biogenesis in human umbilical vein endothelial cells. Diabetes 2006;55:120–7.
Japan Intractable Diseases Information Center. Mitochondrial Disease; Designated Intractable Disease no.: 21. n.d. Available at: www.nanbyou.or.jp/entry/335 [access February 12, 2021].
Shimura M, Nozawa N, Ogawa-Tominaga M, et al. Effects of 5-aminolevulinic acid and sodium ferrous citrate on fibroblasts from individuals with mitochondrial diseases. Sci Rep 2019;9:10549.
Hara T, Koda A, Nozawa N, et al. Combination of 5-aminolevulinic acid and ferrous ion reduces plasma glucose and hemoglobin A1c levels in Zucker diabetic fatty rats. FEBS Open Bio 2016;6:515–28.
Ota U, Hara T, Nakagawa H, et al. 5-aminolevulinic acid combined with ferrous ion reduces adiposity and improves glucose tolerance in diet-induced obese mice via enhancing mitochondrial function. BMC Pharmacol Toxicol 2017;18:7. - Grant Information: no Neopharma Japan Co., Ltd. (JP)
- Accession Number: 0 (Blood Glucose)
0 (Ferrous Compounds)
0 (Insulin)
0 (Levulinic Acids)
2968PHW8QP (Citric Acid)
33KM3X4QQW (ferrous citrate)
8L70Q75FXE (Adenosine Triphosphate) - Subject Terms: Noninsulin-dependent diabetes mellitus with deafness
- Publication Date: Date Created: 20210317 Date Completed: 20210329 Latest Revision: 20231213
- Publication Date: 20231215
- Accession Number: PMC7969291
- Accession Number: 10.1097/MD.0000000000025100
- Accession Number: 33725905
- Source:
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