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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Dead Sea water

Pool water

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Soroka University Medical Cetner

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Dead Sea Water

Pool Water

Arm Description

Outcomes

Primary Outcome Measures

Glucose Levels

Secondary Outcome Measures

HbA1c levels

Full Information

NCT ID

NCT01580852

First Posted

April 16, 2012

Last Updated

April 3, 2019

Sponsor

Victor Novack

1. Study Identification

Unique Protocol Identification Number

NCT01580852

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

May 2012 (Actual)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Victor Novack

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dead Sea Water

Arm Type

Active Comparator

Arm Title

Pool Water

Arm Type

Sham Comparator

Intervention Type

Procedure

Intervention Name(s)

Dead Sea water

Intervention Description

Subjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days

Intervention Type

Procedure

Intervention Name(s)

Pool water

Intervention Description

Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days

Primary Outcome Measure Information:

Title

Glucose Levels

Time Frame

participants will be followed for the duration of hotel stay, an expected average of 5 days

Secondary Outcome Measure Information:

Title

HbA1c levels

Time Frame

three months afer intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Idit Liberty, MD

Organizational Affiliation

Soroka University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Soroka University Medical Cetner

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

12. IPD Sharing Statement

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

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