Type 2 Diabetes MellitusNCT01580852
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
A study testing Dead Sea water and Pool water in people with Type 2 Diabetes Mellitus, run by Victor Novack at 1 site in Israel.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Dead Sea water and Pool water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncontrolled type 2 diabetes mellitus patients(HbA1c levels between 7.5-10)
- Ages 18-65
- Signed Informed Consent
Who cannot join
- Peripheral neuropathy
- Diabetic ulcers or damaged skin
- PVD
- Diabetes diagnosis for over 20 years
- Orthostatic Hypotension
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Dead Sea water, Pool water
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dead Sea waterProcedure or surgery
Subjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days
Pool waterProcedure or surgery
Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days
| Study group | Role | What they receive |
|---|---|---|
| Dead Sea Water | Active comparator | Not described Receives: Procedure: Dead Sea water |
| Pool Water | Sham comparator | Not described Receives: Procedure: Pool water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Levels
Measured: participants will be followed for the duration of hotel stay, an expected average of 5 days
Secondary outcomes (1)
HbA1c levels
Measured: three months afer intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victor Novack
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Victor Novack, Soroka University Medical Center
- Investigators
- Idit Liberty, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580852
- Sponsor's protocol ID
- sor008412clit
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2012
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT01580852
- Acronym / sponsor ID
- sor008412clit
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Victor NovackUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dead Sea Water | Active comparator | Procedure: Dead Sea water |
| Pool Water | Sham comparator | Procedure: Pool water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Uncontrolled type 2 diabetes mellitus patients(HbA1c levels between 7.5-10)
- Ages 18-65
- Signed Informed Consent
Key exclusion criteria (5 listed)
- Peripheral neuropathy
- Diabetic ulcers or damaged skin
- PVD
- Diabetes diagnosis for over 20 years
- Orthostatic Hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dead Sea waterSubjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days | Procedure or surgery | Dead Sea Water |
| Pool waterSubjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days | Procedure or surgery | Pool Water |
Primary outcome
Glucose Levels
Time frame: participants will be followed for the duration of hotel stay, an expected average of 5 days
1 secondary outcome
HbA1c levels
Time frame: three months afer intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idit Liberty, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dead Sea water and Pool water in people with Type 2 Diabetes Mellitus, run by Victor Novack at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Levels (time frame: participants will be followed for the duration of hotel stay, an expected average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.