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

NCT ID: NCT01580852

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dead Sea Water

Group Type ACTIVE_COMPARATOR

Dead Sea water

Intervention Type PROCEDURE

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

Pool Water

Group Type SHAM_COMPARATOR

Pool water

Intervention Type PROCEDURE

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

Interventions

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Dead Sea water

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

Intervention Type PROCEDURE

Pool water

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Victor Novack

OTHER

Sponsor Role lead

Responsible Party

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Victor Novack

Sub Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Idit Liberty, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka University Medical Cetner

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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sor008412clit

Identifier Type: -

Identifier Source: org_study_id

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