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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014