Water-soluble Ubiquinol Supplementation on Blood Glucose, Lipids, Oxidative Stress, and Inflammation in Diabetes

Diabetes Clinical Trial

Official title:

Water-soluble Ubiquinol (a Reduced Form of Coenzyme Q10) Supplementation on Blood Glucose, Lipids, Oxidative Stress, and Inflammation in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622672
• Other study ID #: CS2-15095
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 19, 2015
• Last updated: March 13, 2017
• Start date: January 4, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes is considered an oxidative stress and a chronic inflammatory disease. Coenzyme Q10 (ubiquinone) is recognized as a lipid soluble antioxidant. Ubiquinol is a reduced form of coenzyme Q10 in our body after food or supplements intakes. Studies have indicated that the water-soluble ubiquinol had better antioxidant activity and absorption than lipid-soluble. The purpose of this study was to investigate the effects of a water-soluble ubiquinol supplement (100 mg/d) on antioxidation and anti-inflammation in diabetes patients.

Description:

The patients with type 2 diabetes will recruit as subjects (n = 50) and randomly assign to the placebo (n = 25) or coenzyme Q10 groups (n = 25). The intervention will administer for 12 weeks. The concentrations of coenzyme Q10, oxidative stress marker (malondialdehyde), antioxidant enzymes activities (superoxide dismutase, catalase, and glutathione peroxidase), inflammatory markers [C-reactive protein (CRP), and interleukin-6 (IL-6)], and biochemical parameters (fasting glucose, A1C, insulin, C-peptide, and lipid profiles), and blood pressure will measure. Hopefully, the results of this study could provide the information of water-soluble ubiquinol supplement for clinical doctors and dietitians recommend that diabetes patients deserve to know whether the use of coenzyme Q10 supplement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2017
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• The diagnostic criteria for type 2 diabetes were defined as a glycohemoglobin (A1C) ? 6.5%, a fasting glucose ? 7.0 mmol/L or a 2-h plasma glucose ? 200 mmol/L during an oral glucose tolerance test (OGTT), as well as the use of anti-hyperglycemic drugs.

Exclusion Criteria:

• pregnant or lactation women.

• patients with liver or renal disease

• Antioxidant dietary supplements user.

• patients under warfarin therapy.

• patients with hypoglycemia (fasting glucose < 60 mg/dL) or hyperlipidemia (fasting triglyceride ? 500 mg/dL)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Inflammation

Intervention

Dietary Supplement:
• water-soluble ubiquinol
100 mg/d
• Placebo
glycerin.soy-lecithin, and water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yeh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	serum level of fasting glucose in mmol/L.	12 weeks
Secondary	Low density lipoprotein-cholesterol (LDL-C)	serum level of LDL-C in mmol/L.	12 weeks
Secondary	high density lipoprotein-cholesterol (HDL-C)	serum level of HDL-C in mmol/L.	12 weeks
Secondary	malondialdehyde (MDA)	plasma level of MDA in micromol/L.	12 weeks
Secondary	catalase (CAT)	red blood cells level of CAT in Units/mg protein.	12 weeks
Secondary	superoxide dismutase (SOD)	red blood cells level of SOD in Units/mg protein.	12 weeks
Secondary	glutathione peroxidase (GPx)	red blood cells level of GPx in Units/mg protein.	12 weeks
Secondary	high sensitivity C-reactive protein (hs-CRP)	serum level of hs-CRP in mg/L.	12 weeks
Secondary	high sensitivity interleukin (hs-IL-6)	serum level of hs-IL-6 in pg/mL.	12 weeks