Clinical trial NCT02622672: Water-soluble Ubiquinol Supplementation on Blood Glucose, Lipids, Oxidative Stress, and Inflammation in Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes
Keywords: Antioxidation
Anti-inflammation
Blood glucose
Blood lipids
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fasting glucose
timeFrame: 12 weeks
Secondary outcomes:
measure: Low density lipoprotein-cholesterol (LDL-C)
timeFrame: 12 weeks
measure: high density lipoprotein-cholesterol (HDL-C)
timeFrame: 12 weeks
measure: malondialdehyde (MDA)
timeFrame: 12 weeks
measure: catalase (CAT)
timeFrame: 12 weeks
measure: superoxide dismutase (SOD)
timeFrame: 12 weeks
measure: glutathione peroxidase (GPx)
timeFrame: 12 weeks
measure: high sensitivity C-reactive protein (hs-CRP)
timeFrame: 12 weeks
measure: high sensitivity interleukin (hs-IL-6)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: School of Nutrition, Chung Shan Medical University
name: Ping-Ting Lin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: