Type 2 DiabetesNCT05842993
Study of Hydrogen Inhalation Compared With Placebo in Type 2 Diabetes Patients
A study testing Hydrogen generator and Analogue machine in people with Type 2 Diabetes, run by Qingdao University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of hydrogen inhalation in type 2 diabetes patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Hydrogen generator and Analogue machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Mental and neurological disorders, unable to correctly express their wishes;
- Alcoholics and drug abusers and addicts;
- 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);
- Patients who have participated in clinical trials of other drugs or medical devices in the past 3 months;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qingdao Traditional Chinese Medicine Hospital
Qingdao, Shandong, 266000
Tongshang Ni, Ph.D, +86 17354605382, neetongshang@126.com
About this study
Official title: Efficacy and Safety of Hydrogen Inhalation in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of hydrogen inhalation in type 2 diabetes patients.
Read the 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
- Being tested
- Hydrogen generator, Analogue machine
- Keywords
- type 2 diabetes mellitus, hydrogen inhalation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen generatorDevice
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.
Analogue machineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen inhalation | Experimental | Patients receive hydrogen inhalation. Receives: Device: Hydrogen generator |
| Placebo | Placebo comparator | Patients receive placebo. Receives: Device: Analogue machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated hemoglobin (HbA1c)
The change in HbA1c from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Measured: Baseline and Week 12
Secondary outcomes (13)
Change in fasting plasma glucose (FPG)
The change in FPG from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Measured: 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.
Measured: Baseline and Week 12
Patients with HbA1c <7.0%
Percentage of patients reaching HbA1c <7% at Week 12
Measured: At Week 12
Patients with HbA1c <6.5%
Percentage of patients reaching HbA1c <6.5% at Week 12
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Change in serum lipid profile
The change in total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides from baseline to Week 12 in hydrogen inhalation group compared to Placebo.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2023
- Primary completion10 Oct 2023 (estimated)
- Study completion10 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao Hiser Medical Group
- Responsible party
- Principal investigator, Tongshang Ni, Qingdao University
- Investigators
- Tongshang Ni, Ph.D, Principal investigator, Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842993
- Sponsor's protocol ID
- QDU-HD-2023/1732
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hydrogen Inhalation in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05842993
- Acronym / sponsor ID
- QDU-HD-2023/1732
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes mellitus, hydrogen inhalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Collaborators
- Qingdao Hiser Medical Group
- Study start
- 1 May 2023 (actual)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen inhalation | Experimental | Device: Hydrogen generatorPatients receive hydrogen inhalation. |
| Placebo | Placebo comparator | Device: Analogue machinePatients receive placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (20 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen generatorPatient 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. | Device | Hydrogen inhalation |
| Analogue machinePatient 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. | Device | Placebo |
Primary outcome
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.
13 secondary outcomes
Change in fasting plasma glucose (FPG)
Time frame: Baseline and Week 12
Change in 2h-postprandial plasma glucose (2h-PPG)
Time frame: Baseline and Week 12
Patients with HbA1c <7.0%
Time frame: At Week 12
Patients with HbA1c <6.5%
Time frame: At Week 12
Change in fasting plasma insulin
Time frame: Baseline and Week 12
Change in insulin sensitivity and beta cell function assessed by the homeostatic model assessment (HOMA)
Time frame: Baseline and Week 12
Change in serum lipid profile
Time frame: Baseline and Week 12
Change in waist circumference
Time frame: Baseline and Week 12
Change in body weight
Time frame: Baseline and Week 12
Change in body mass index (BMI)
Time frame: Baseline and Week 12
Change in blood pressure
Time frame: Baseline and Week 12
Change in oxidative stress index and inflammatory index
Time frame: Baseline and Week 12
Safety measurement
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tongshang Ni, Ph.D principal investigator
Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen generator and Analogue machine in people with Type 2 Diabetes, run by Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tongshang Ni, Ph.D (+86 17354605382, neetongshang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycosylated hemoglobin (HbA1c) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.