- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01580852
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beer Sheva, Israel, 84101
- Soroka University Medical Cetner
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dead Sea Water
|
Subjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days
|
Sham Comparator: Pool Water
|
Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose Levels
Time Frame: participants will be followed for the duration of hotel stay, an expected average of 5 days
|
participants will be followed for the duration of hotel stay, an expected average of 5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c levels
Time Frame: three months afer intervention
|
three months afer intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Idit Liberty, MD, Soroka University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sor008412clit
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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