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The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients

This study is not yet open for participant recruitment.
Verified April 2012 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
Idit F Liberty, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01580852
First received: April 16, 2012
Last updated: April 18, 2012
Last verified: April 2012
History of Changes

April 16, 2012
April 18, 2012
July 2012
November 2012   (final data collection date for primary outcome measure)
Glucose Levels [ Time Frame: participants will be followed for the duration of hotel stay, an expected average of 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01580852 on ClinicalTrials.gov Archive Site
HbA1c levels [ Time Frame: three months afer intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Procedure: Dead Sea water
    Subjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days
  • Procedure: Pool water
    Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days
  • Active Comparator: Dead Sea Water
    Intervention: Procedure: Dead Sea water
  • Sham Comparator: Pool Water
    Intervention: Procedure: Pool water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Idit Liberty, MD iliberty@bgu.ac.il
Israel
 
NCT01580852
sor008412clit
No
Idit F Liberty, Soroka University Medical Center
Idit F Liberty
Not Provided
Principal Investigator: Idit Liberty, MD Soroka University Medical Center
Soroka University Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP