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Study of Hydrogen-rich Water Compared With Placebo in Type 2 Diabetes Patients

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydrogen-rich water
placebo
Sponsored by
Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes mellitus, hydrogen-rich water

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; 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.

Sites / Locations

  • Qingdao Traditional Chinese Medicine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrogen-rich water

Placebo

Arm Description

Patients receive hydrogen-rich water.

Patients receive placebo.

Outcomes

Primary Outcome Measures

Change in glycosylated hemoglobin (HbA1c)
The change in HbA1c from baseline to Week 12 in hydrogen-rich water group compared to Placebo.

Secondary Outcome Measures

Change in fasting plasma glucose (FPG)
The change in FPG from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Change in 2h-postprandial plasma glucose (2h-PPG)
The change in 2h-PPG from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Patients with HbA1c <7.0%
Percentage of patients reaching HbA1c <7% at Week 12
Patients with HbA1c <6.5%
Percentage of patients reaching HbA1c <6.5% at Week 12
Change in fasting plasma insulin
The change in fasting plasma insulin from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
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-rich water group compared to Placebo.
Change in serum lipid profile
The change in total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Change in waist circumference
The change in waist circumference from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Change in body weight
The change in body weight from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Change in body mass index (BMI)
The change in BMI from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Change in blood pressure
The change in blood pressure from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
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.
Number of participants with adverse events as a measure of safety and tolerability
Number of participants with adverse events from baseline to Week 12.

Full Information

First Posted
May 27, 2023
Last Updated
June 6, 2023
Sponsor
Qingdao University
Collaborators
Qingdao Hiser Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT05905588
Brief Title
Study of Hydrogen-rich Water Compared With Placebo in Type 2 Diabetes Patients
Official Title
Efficacy and Safety of Hydrogen-rich Water in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao University
Collaborators
Qingdao Hiser Medical Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of hydrogen-rich water in type 2 diabetes patients.
Detailed Description
The objective of the study is to evaluate the efficacy and safety of hydrogen-rich water compared with placebo in patients with type 2 diabetes mellitus after 12-week treatment in a randomized, double-blind, placebo-controlled design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes mellitus, hydrogen-rich water

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrogen-rich water
Arm Type
Experimental
Arm Description
Patients receive hydrogen-rich water.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrogen-rich water
Intervention Description
Patients drink 600mL hydrogen-rich water per day by applying hydrogen-rich water cup (Qingdao Haizhisheng Corp.,LTD, Qingdao, China) for 12 weeks. The dissolved hydrogen concentration is 5 ppm.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Patients drink 600mL tap water per day by applying analogue cup for 12 weeks. This cup has the same appearance as the hydrogen-rich water cup, and the hydrogen-rich water and placebo water were indistinguishable. The dissolved hydrogen concentration is 0 ppm in placebo water.
Primary Outcome Measure Information:
Title
Change in glycosylated hemoglobin (HbA1c)
Description
The change in HbA1c from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change in fasting plasma glucose (FPG)
Description
The change in FPG from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Change in 2h-postprandial plasma glucose (2h-PPG)
Description
The change in 2h-PPG from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Patients with HbA1c <7.0%
Description
Percentage of patients reaching HbA1c <7% at Week 12
Time Frame
At Week 12
Title
Patients with HbA1c <6.5%
Description
Percentage of patients reaching HbA1c <6.5% at Week 12
Time Frame
At Week 12
Title
Change in fasting plasma insulin
Description
The change in fasting plasma insulin from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Change in insulin sensitivity and beta cell function assessed by the homeostatic model assessment (HOMA)
Description
The change in HOMA-IR and HOMA-β from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Change in serum lipid profile
Description
The change in total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Change in waist circumference
Description
The change in waist circumference from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Change in body weight
Description
The change in body weight from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Change in body mass index (BMI)
Description
The change in BMI from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Change in blood pressure
Description
The change in blood pressure from baseline to Week 12 in hydrogen-rich water group compared to Placebo.
Time Frame
Baseline and Week 12
Title
Change in oxidative stress index and inflammatory index
Description
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
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
Number of participants with adverse events from baseline to Week 12.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tongshang Ni, Ph.D
Phone
+86 17354605382
Email
neetongshang@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tongshang Ni, Ph.D
Organizational Affiliation
Qingdao Universtiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qingdao Traditional Chinese Medicine Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongshang Ni, Ph.D
Phone
+86 17354605382
Email
neetongshang@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Hydrogen-rich Water Compared With Placebo in Type 2 Diabetes Patients

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