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

April 3, 2019 updated by: Victor Novack

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Cetner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Victor Novack

Investigators

  • Principal Investigator: Idit Liberty, MD, Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

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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