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

NCT05842993 | Unknown

• 1 other identifier: QDU-HD-2023/1732
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes mellitus; hydrogen inhalation

Outcome Measures

Primary Outcomes (1)

• Change in glycosylated hemoglobin (HbA1c)

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

  Baseline and Week 12

Secondary Outcomes (13)

• Change in fasting plasma glucose (FPG)

  Baseline and Week 12

• Change in 2h-postprandial plasma glucose (2h-PPG)

  Baseline and Week 12

• Patients with HbA1c <7.0%

  At Week 12

• Patients with HbA1c <6.5%

  At Week 12

• Change in fasting plasma insulin

  Baseline and Week 12

Study Arms (2)

Hydrogen inhalation

EXPERIMENTAL

Patients receive hydrogen inhalation.

Device: Hydrogen generator

Placebo

PLACEBO COMPARATOR

Patients receive placebo.

Device: Analogue machine

Interventions

Hydrogen generator 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.

Hydrogen inhalation

Analogue machine 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Had malignancy in the past 5 years, not including basal cell carcinoma;
• History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);
• Combined use of drugs that affect glucose metabolism, such as glucocorticoids;
• Combined use of Chinese herbal medicine with the effect of regulating blood glucose within 3 months;
• Those who have serious diseases and may be in danger of life during treatment and follow-up;

Sponsors & Collaborators

• Qingdao University: lead
• Qingdao Hiser Medical Group: collaborator

Study Sites (1)

Qingdao Traditional Chinese Medicine Hospital

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tongshang Ni, Ph.D

  Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tongshang Ni, Ph.D

CONTACT

+86 17354605382; neetongshang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)