Study of Hydrogen Inhalation Compared With Placebo in Type 2 Diabetes Patients

NCT ID: NCT05842993

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-10-10

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hydrogen inhalation

Patients receive hydrogen inhalation.

Group Type: EXPERIMENTAL

Hydrogen generator

Intervention Type: DEVICE

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.

Placebo

Patients receive placebo.

Group Type: PLACEBO_COMPARATOR

Analogue machine

Intervention Type: DEVICE

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.

Interventions

Hydrogen generator

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.

Intervention Type: DEVICE

Analogue machine

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged 18-75 years old and gender of both sex;

2. Body mass index 18.5kg/m2 to 40 kg/m2;

3. Diagnosed as type 2 diabetes according to the diagnostic criteria of type 2 diabetes established by WHO in 1999;

4. Patients with type 2 diabetes whose blood glucose is not well controlled after diet control and exercise therapy for more than 3 months;

5. HbA1c 7% to 10%, and fasting venous plasma glucose ≤ 15 mmol/L;

6. Be able to understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent.

Exclusion Criteria

1. Type 1 diabetes, gestational diabetes, or other specific types of diabetes;

2. 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;

3. History of diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome, lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy;

4. Hyperlipidemia patients with irregular or unstable dose of lipid-lowering drugs

5. Chronic gastrointestinal disorders with obvious digestive and absorption disorders, as well as other endocrine diseases, such as hyperthyroidism, hypercortisolism, acromegaly, etc.;

6. Patients with diseases that may worsen due to intestinal flatulence (such as Roemheld syndrome, severe hernia, intestinal obstruction, intestinal surgery and intestinal ulcers);

7. 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;

8. Subjects (taking or not taking antihypertensive drugs) had poor blood pressure control (SBP ≥ 160mmhg, or DBP ≥ 100mmhg);

9. liver disease, ALT or AST > 2 ULN, or TBIL > 2 ULN, and the diagnosis was confirmed within one week;

10. Patients with renal function impairment (Cr > 1 ULN or Ccr < 60ml / min) and confirmed by reexamination within one week;

11. Had malignancy in the past 5 years, not including basal cell carcinoma;

12. History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);

13. Combined use of drugs that affect glucose metabolism, such as glucocorticoids;

14. Combined use of Chinese herbal medicine with the effect of regulating blood glucose within 3 months;

15. Those who have serious diseases and may be in danger of life during treatment and follow-up;

16. Mental and neurological disorders, unable to correctly express their wishes;

17. Alcoholics and drug abusers and addicts;

18. Women of childbearing age are pregnant, breastfeeding, have pregnancy intentions or have a positive pregnancy test (urine HCG or blood HCG), and should not take effective contraceptive measures during the trial (effective contraceptive measures include sterilization, intrauterine device, oral contraceptive or diaphragm method prescribed by local law);

19. Patients who have participated in clinical trials of other drugs or medical devices in the past 3 months;

20. Patients with other diseases that the researchers believe will not be able to evaluate or are unlikely to complete the expected course of treatment and follow-up.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qingdao Hiser Medical Group

OTHER

Sponsor Role: collaborator

Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Tongshang Ni

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tongshang Ni, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Qingdao University

Locations

Qingdao Traditional Chinese Medicine Hospital

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tongshang Ni, Ph.D

Role: CONTACT

neetongshang@126.com

+86 17354605382

Facility Contacts

Tongshang Ni, Ph.D

Role: primary

neetongshang@126.com

+86 17354605382

Other Identifiers

QDU-HD-2023/1732

Identifier Type: -

Identifier Source: org_study_id