The purpose of this study is to evaluate the efficacy and safety of hydrogen inhalation in type 2 diabetes patients.
The objective of the study is to evaluate the efficacy and safety of hydrogen inhalation compared with placebo in patients with type 2 diabetes mellitus after 12-week treatment in a randomized, double-blind, placebo-controlled design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Patient inhales hydrogen gas for 2 hours per day in the flow rate of 2L/min via nasal cannula by applying hydrogen generator (HZS-2700A, Qingdao Haizhisheng Corp.,LTD, Qingdao, China) for 12 weeks.
Patient inhales normal air for 2 hours per day in the flow rate of 2L/min via nasal cannula with analogue machine for 12 weeks. This machine has the same appearance as the hydrogen generator.
Qingdao Traditional Chinese Medicine Hospital
Qingdao, Shandong, China
RECRUITINGChange in glycosylated hemoglobin (HbA1c)
The change in HbA1c from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in fasting plasma glucose (FPG)
The change in FPG from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in 2h-postprandial plasma glucose (2h-PPG)
The change in 2h-PPG from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Patients with HbA1c <7.0%
Percentage of patients reaching HbA1c \<7% at Week 12
Time frame: At Week 12
Patients with HbA1c <6.5%
Percentage of patients reaching HbA1c \<6.5% at Week 12
Time frame: At Week 12
Change in fasting plasma insulin
The change in fasting plasma insulin from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in insulin sensitivity and beta cell function assessed by the homeostatic model assessment (HOMA)
The change in HOMA-IR and HOMA-β from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in serum lipid profile
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The change in total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in waist circumference
The change in waist circumference from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in body weight
The change in body weight from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in body mass index (BMI)
The change in BMI from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in blood pressure
The change in blood pressure from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Time frame: Baseline and Week 12
Change in oxidative stress index and inflammatory index
Serum MDA and SOD, TNF-α, IL-6 quantifications were conducted using commercial kits from baseline to Week 12.
Time frame: Baseline and Week 12
Safety measurement
The incidence rates of adverse events, clinical findings in the physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory tests (hematology, blood biochemistry, and urinalysis) from baseline to Week 12.
Time frame: Baseline to Week 12