Type 2 Diabetes Mellitus Clinical Trial
Official title:
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
| NCT number | NCT01580852 |
| Other study ID # | sor008412clit |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2012 |
| Est. completion date | April 2014 |
| Verified date | April 2019 |
| Source | Soroka University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Soroka University Medical Cetner | Beer Sheva |
| Lead Sponsor | Collaborator |
|---|---|
| Victor Novack |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glucose Levels | participants will be followed for the duration of hotel stay, an expected average of 5 days | ||
| Secondary | HbA1c levels | three months afer intervention |
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