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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
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
 Procedure: Dead Sea water
Procedure: Pool water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • HbA1c levels [ Time Frame: three months afer intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dead Sea Water Procedure: 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 Procedure: Pool water
Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580852

Contacts
Contact: Idit Liberty, MD iliberty@bgu.ac.il

Locations
Israel
Soroka University Medical Cetner Not yet recruiting
Beer Sheva, Israel, 84101
Contact: Idit Liberty, MD     972-50-6264572     iliberty@bgu.ac.il    
Principal Investigator: Idit Liberty, MD            
Sponsors and Collaborators
Idit F Liberty
Investigators
Principal Investigator: Idit Liberty, MD Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Idit F Liberty, Principal Investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01580852     History of Changes
Other Study ID Numbers: sor008412clit
Study First Received: April 16, 2012
Last Updated: April 18, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013