Efficacy and Safety of Hydrogen Inhalation in Subjects With Type 2 Diabetes

Qingdao University1 site in 1 country96 target enrollmentMay 1, 2023

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Qingdao University
Enrollment: 96
Locations: 1
Primary Endpoint: Change in glycosylated hemoglobin (HbA1c)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hydrogen inhalation in type 2 diabetes patients.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

October 10, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Qingdao University

Responsible Party

Principal Investigator

Tongshang Ni

Lecturer

Qingdao University

Eligibility Criteria

Inclusion Criteria

•Aged 18-75 years old and gender of both sex;
•Body mass index 18.5kg/m2 to 40 kg/m2;
•Diagnosed as type 2 diabetes according to the diagnostic criteria of type 2 diabetes established by WHO in 1999;
•Patients with type 2 diabetes whose blood glucose is not well controlled after diet control and exercise therapy for more than 3 months;
•HbA1c 7% to 10%, and fasting venous plasma glucose ≤ 15 mmol/L;
•Be able to understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent.

Exclusion Criteria

•Type 1 diabetes, gestational diabetes, or other specific types of diabetes;
•Screening for having received anti-diabetic drug therapy within 3 months or receiving continuous anti-diabetic drug therapy at any time before screening for more than 3 months;
•History of diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome, lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy;
•Hyperlipidemia patients with irregular or unstable dose of lipid-lowering drugs
•Chronic gastrointestinal disorders with obvious digestive and absorption disorders, as well as other endocrine diseases, such as hyperthyroidism, hypercortisolism, acromegaly, etc.;
•Patients with diseases that may worsen due to intestinal flatulence (such as Roemheld syndrome, severe hernia, intestinal obstruction, intestinal surgery and intestinal ulcers);
•Had transient ischemic attack, cerebrovascular accident or unstable angina in the past 6 months; History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery; Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;
•Subjects (taking or not taking antihypertensive drugs) had poor blood pressure control (SBP ≥ 160mmhg, or DBP ≥ 100mmhg);
•liver disease, ALT or AST \> 2 ULN, or TBIL \> 2 ULN, and the diagnosis was confirmed within one week;
•Patients with renal function impairment (Cr \> 1 ULN or Ccr \< 60ml / min) and confirmed by reexamination within one week;

Outcomes

Primary Outcomes

Change in glycosylated hemoglobin (HbA1c)

Time Frame: Baseline and Week 12

The change in HbA1c from baseline to Week 12 in hydrogen inhalation group compared to Placebo.

Secondary Outcomes

Patients with HbA1c <6.5%(At Week 12)
Change in body mass index (BMI)(Baseline and Week 12)
Change in oxidative stress index and inflammatory index(Baseline and Week 12)
Change in fasting plasma glucose (FPG)(Baseline and Week 12)
Change in 2h-postprandial plasma glucose (2h-PPG)(Baseline and Week 12)
Change in fasting plasma insulin(Baseline and Week 12)
Change in insulin sensitivity and beta cell function assessed by the homeostatic model assessment (HOMA)(Baseline and Week 12)
Change in serum lipid profile(Baseline and Week 12)
Change in blood pressure(Baseline and Week 12)
Patients with HbA1c <7.0%(At Week 12)
Change in waist circumference(Baseline and Week 12)
Change in body weight(Baseline and Week 12)
Safety measurement(Baseline to Week 12)