LipedemaNCT07779577
Serum Magnesium Levels in Patients Diagnosed With Lipedema
An observational study of Lipedema and Magnesium, run by Fatih Sultan Mehmet Training and Research Hospital.
Trial summary
Female patients diagnosed with lipedema will be divided into two groups based on their Pittsburgh Sleep Quality Index (PSQI) scores: PSQI ≤ 5 and PSQI > 5. Age, body mass index (BMI), education level, menopausal status (reproductive period, perimenopausal period, postmenopausal period), number of births, duration of… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Magnesium
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 16 Aug 2026to 16 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lipedema who are 18 years of age or older
Who may be able to join
- Serum magnesium levels must have been measured within the past 6 month
- Be at least 18 years of age
- Have a diagnosis of lipedema based on the Wold criteria
- Have no cognitive or mental health issues
- Agree to participate in the study
Who cannot join
- No serum magnesium level measured within the past 6 months
- Use of magnesium supplements for lipedema within the past 6 months, or the presence of any condition known to affect magnesium absorption or serum magnesium levels (e.g., use of a proton pump inhibitor [PPI] or diuretic)
- The presence of other types of edema in which a component other than lipedema is predominant (e.g., lymphedema, venous edema, edema associated with heart or kidney failure, etc.)
- A body mass index (BMI) of over 50.0 (this condition reflects severe obesity, which has a significant impact on health beyond lipedema alone)
- Presence of a rheumatological disease, history of cancer, chronic liver disease, or endocrine disorder
- Having been diagnosed with a psychiatric disorder, or use of psychiatric medications that may affect sleep
- Being under 18 years of age
About this study
Official title: The Relationship Between Serum Magnesium Levels and Sleep Quality, Pain Levels, and Quality of Life in Patients Diagnosed With Lipedema: An Observational Cross-Sectional Study
Female patients diagnosed with lipedema will be divided into two groups based on their Pittsburgh Sleep Quality Index (PSQI) scores: PSQI ≤ 5 and PSQI > 5. Age, body mass index (BMI), education level, menopausal status (reproductive period, perimenopausal period, postmenopausal period), number of births, duration of illness, occupation, marital status, disease stage, lipedema type, lower extremity functional scale, and the World Health Organization Quality of Life Scale - Short Form (Physical Health, Psychological Health, Social Relationships...)
Read the detailed description
Female patients diagnosed with lipedema will be divided into two groups based on their Pittsburgh Sleep Quality Index (PSQI) scores: PSQI ≤ 5 and PSQI > 5. Age, body mass index (BMI), education level, menopausal status (reproductive period, perimenopausal period, postmenopausal period), number of births, duration of illness, occupation, marital status, disease stage, lipedema type, lower extremity functional scale, and the World Health Organization Quality of Life Scale - Short Form (Physical Health, Psychological Health, Social Relationships...) Inclusion criteria for the study: Serum magnesium levels must have been measured within the past 6 months; participants must be over 18 years of age; a diagnosis of lipedema must have been made according to the Wold criteria; participants must not have any cognitive or mental health issues; and they must agree to participate in the study. Exclusion criteria include the absence of serum magnesium levels within the past 6 months, the use of magnesium supplements for lipedema over the past 6 months, or the presence of any condition known to affect magnesium absorption or serum magnesium levels (e.g., use of a proton pump inhibitor [PPI] or a diuretic), or the presence of other types of edema in which a component other than lipedema is predominant (e.g., lymphedema, venous edema, edema due to heart or kidney failure, etc.), Chronic liver disease, a body mass index (BMI) of over 50.0 (this condition reflects severe obesity that has a significant impact on health, rather than lipedema alone), the presence of a rheumatological disease, a history of cancer, the presence of an endocrine disorder, a diagnosis of a psychiatric disorder, the use of psychiatric medications that may affect sleep, and being under 18 years of age.
- Being tested
- Magnesium
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumOther
serum magnesium level
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Patients with lipedema who have a Pittsburgh Sleep Quality Index (PSQI) score of ≤ 5 Receives: Other: Magnesium | |
| Group2 | Patients with lipedema who have a Pittsburgh Sleep Quality Index (PSQI) score of > 5 Receives: Other: Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between serum magnesium levels and the Pittsburgh Sleep Quality Index (PSQI) score
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start16 Aug 2026 (estimated)
- Primary completion16 Sep 2026 (estimated)
- Study completion16 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779577
- Sponsor's protocol ID
- FSMLIPEDEMAMG
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum Magnesium Levels and Sleep Quality, Pain Levels, and Quality of Life in Patients Diagnosed With Lipedema: An Observational Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07779577
- Acronym / sponsor ID
- FSMLIPEDEMAMG
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 16 Aug 2026 (estimated)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 16 Sep 2026 (estimated)
- First posted
- 21 Aug 2026 (actual)
- 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.
Female patients diagnosed with lipedema will be divided into two groups based on their Pittsburgh Sleep Quality Index (PSQI) scores: PSQI ≤ 5 and PSQI > 5. Age, body mass index (BMI), education level, menopausal status (reproductive period, perimenopausal period, postmenopausal period), number of births, duration of illness, occupation, marital status, disease stage, lipedema type, lower extremity functional scale, and the World Health Organization Quality of Life Scale - Short Form (Physical Health, Psychological Health, Social Relationships...)
Detailed description
Female patients diagnosed with lipedema will be divided into two groups based on their Pittsburgh Sleep Quality Index (PSQI) scores: PSQI ≤ 5 and PSQI > 5. Age, body mass index (BMI), education level, menopausal status (reproductive period, perimenopausal period, postmenopausal period), number of births, duration of illness, occupation, marital status, disease stage, lipedema type, lower extremity functional scale, and the World Health Organization Quality of Life Scale - Short Form (Physical Health, Psychological Health, Social Relationships...) Inclusion criteria for the study: Serum magnesium levels must have been measured within the past 6 months; participants must be over 18 years of age; a diagnosis of lipedema must have been made according to the Wold criteria; participants must not have any cognitive or mental health issues; and they must agree to participate in the study. Exclusion criteria include the absence of serum magnesium levels within the past 6 months, the use of magnesium supplements for lipedema over the past 6 months, or the presence of any condition known to affect magnesium absorption or serum magnesium levels (e.g., use of a proton pump inhibitor [PPI] or a diuretic), or the presence of other types of edema in which a component other than lipedema is predominant (e.g., lymphedema, venous edema, edema due to heart or kidney failure, etc.), Chronic liver disease, a body mass index (BMI) of over 50.0 (this condition reflects severe obesity that has a significant impact on health, rather than lipedema alone), the presence of a rheumatological disease, a history of cancer, the presence of an endocrine disorder, a diagnosis of a psychiatric disorder, the use of psychiatric medications that may affect sleep, and being under 18 years of age.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Other: MagnesiumPatients with lipedema who have a Pittsburgh Sleep Quality Index (PSQI) score of ≤ 5 |
| Group2 | – | Other: MagnesiumPatients with lipedema who have a Pittsburgh Sleep Quality Index (PSQI) score of > 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lipedema who are 18 years of age or older
Key inclusion criteria (5 listed)
- Serum magnesium levels must have been measured within the past 6 month
- Be at least 18 years of age
- Have a diagnosis of lipedema based on the Wold criteria
- Have no cognitive or mental health issues
- Agree to participate in the study
Key exclusion criteria (7 listed)
- No serum magnesium level measured within the past 6 months
- Use of magnesium supplements for lipedema within the past 6 months, or the presence of any condition known to affect magnesium absorption or serum magnesium levels (e.g., use of a proton pump inhibitor [PPI] or diuretic)
- The presence of other types of edema in which a component other than lipedema is predominant (e.g., lymphedema, venous edema, edema associated with heart or kidney failure, etc.)
- A body mass index (BMI) of over 50.0 (this condition reflects severe obesity, which has a significant impact on health beyond lipedema alone)
- Presence of a rheumatological disease, history of cancer, chronic liver disease, or endocrine disorder
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 |
|---|---|---|
| Magnesiumserum magnesium level | Other | Group1, Group2 |
Primary outcome
The relationship between serum magnesium levels and the Pittsburgh Sleep Quality Index (PSQI) score
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema and Magnesium, run by Fatih Sultan Mehmet Training and Research Hospital.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
The relationship between serum magnesium levels and the Pittsburgh Sleep Quality Index (PSQI) score (time frame: 1 day). 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 21 Aug 2026.