NCT01580852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

April 16, 2012

Last Update Submit

April 3, 2019

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Glucose Levels

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

Secondary Outcomes (1)

  • HbA1c levels

    three months afer intervention

Study Arms (2)

Dead Sea Water

ACTIVE COMPARATOR
Procedure: Dead Sea water

Pool Water

SHAM COMPARATOR
Procedure: Pool water

Interventions

Dead Sea waterPROCEDURE

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

Dead Sea Water
Pool waterPROCEDURE

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

Pool Water

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncontrolled type 2 diabetes mellitus patients(HbA1c levels between 7.5-10)
  • Ages 18-65
  • Signed Informed Consent

You may not qualify if:

  • Peripheral neuropathy
  • Diabetic ulcers or damaged skin
  • PVD
  • Diabetes diagnosis for over 20 years
  • Orthostatic Hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Cetner

Beersheba, 84101, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Idit Liberty, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sub Investigator

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 19, 2012

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

IL(1)