The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dead Sea water
Pool water
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Uncontrolled type 2 diabetes mellitus patients(HbA1c levels between 7.5-10)
- Ages 18-65
- Signed Informed Consent
Exclusion Criteria:
- Peripheral neuropathy
- Diabetic ulcers or damaged skin
- PVD
- Diabetes diagnosis for over 20 years
- Orthostatic Hypotension
Sites / Locations
- Soroka University Medical Cetner
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Dead Sea Water
Pool Water
Arm Description
Outcomes
Primary Outcome Measures
Glucose Levels
Secondary Outcome Measures
HbA1c levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01580852
Brief Title
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
Official Title
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Victor Novack
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
BACKGROUND: Bathing in sweet or mineral water can induce significant physiological changes in several body systems including the endocrine system. To date, there have only been a small number of reports that balneology can reduce blood sugar Levels in patients with type 2 diabetes mellitus (DM].
OBJECTIVE: To compare the effects of a immersion in sweet or mineral water on blood glucose levels in patients with type 2 DM.
METHODS: Forty patients with type 2 DM will immerse in either sweet or mineral water twice daily. In both cases the water will be warmed to a temperature of 35 degrees C and the bath continue for 20 minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dead Sea Water
Arm Type
Active Comparator
Arm Title
Pool Water
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Dead Sea water
Intervention Description
Subjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days
Intervention Type
Procedure
Intervention Name(s)
Pool water
Intervention Description
Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days
Primary Outcome Measure Information:
Title
Glucose Levels
Time Frame
participants will be followed for the duration of hotel stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
HbA1c levels
Time Frame
three months afer intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uncontrolled type 2 diabetes mellitus patients(HbA1c levels between 7.5-10)
Ages 18-65
Signed Informed Consent
Exclusion Criteria:
Peripheral neuropathy
Diabetic ulcers or damaged skin
PVD
Diabetes diagnosis for over 20 years
Orthostatic Hypotension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idit Liberty, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Cetner
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
12. IPD Sharing Statement
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The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
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