跳至主要内容
临床试验/NCT07779577
NCT07779577尚未招募不适用

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

Fatih Sultan Mehmet Training and Research Hospital0 个研究点目标入组 128 人开始时间: 2026年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
128
主要终点
The relationship between serum magnesium levels and the Pittsburgh Sleep Quality Index (PSQI) score

研究概览

简要总结

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...)

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Group1

Patients with lipedema who have a Pittsburgh Sleep Quality Index (PSQI) score of ≤ 5

干预措施: Magnesium (Other)

Group2

Patients with lipedema who have a Pittsburgh Sleep Quality Index (PSQI) score of > 5

干预措施: Magnesium (Other)

结局指标

主要结局

The relationship between serum magnesium levels and the Pittsburgh Sleep Quality Index (PSQI) score

时间窗: 1 day

次要结局

未报告次要终点

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

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