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

Efficacy and Safety of Hydrogen-rich Water in Subjects With Type 2 Diabetes

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Hydrogen-rich water; Dietary supplement: placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tongshang Ni, Ph.D; Phone Number: +86 17354605382; Email: neetongshang@126.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • Qingdao Traditional Chinese Medicine Hospital
      • Contact: Tongshang Ni, Ph.D; Phone Number: +86 17354605382; Email: neetongshang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients receive placebo.	Dietary supplement: placebo; 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.
Experimental: Hydrogen-rich water; Patients receive hydrogen-rich water.	Dietary supplement: Hydrogen-rich water; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycosylated hemoglobin (HbA1c)	The change in HbA1c from baseline to Week 12 in hydrogen-rich water group compared to Placebo.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients with HbA1c <7.0%	Percentage of patients reaching HbA1c <7% at Week 12	At Week 12
Patients with HbA1c <6.5%	Percentage of patients reaching HbA1c <6.5% at Week 12	At 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.	Baseline and Week 12
Change in fasting plasma glucose (FPG)	The change in FPG from baseline to Week 12 in hydrogen-rich water group compared to Placebo.	Baseline and Week 12
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.	Baseline and 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.	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-rich water group compared to Placebo.	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-rich water group compared to Placebo.	Baseline and Week 12
Change in waist circumference	The change in waist circumference from baseline to Week 12 in hydrogen-rich water group compared to Placebo.	Baseline and Week 12
Change in body weight	The change in body weight from baseline to Week 12 in hydrogen-rich water group compared to Placebo.	Baseline and Week 12
Change in body mass index (BMI)	The change in BMI from baseline to Week 12 in hydrogen-rich water group compared to Placebo.	Baseline and Week 12
Change in blood pressure	The change in blood pressure from baseline to Week 12 in hydrogen-rich water group compared to Placebo.	Baseline and 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.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Qingdao University
• Collaborators: Qingdao Hiser Medical Group
• Investigators: Principal Investigator: Tongshang Ni, Ph.D, Qingdao Universtiy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): August 31, 2023
• Study Completion (Estimated): August 31, 2023

Study Registration Dates

• First Submitted: May 27, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; hydrogen-rich water
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: QDU-HD-2023/1803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No