Study of Human Adipose Tissue (LOSHAT) (LOSHAT)
2020年9月2日 更新者：Peter Arner、Karolinska University Hospital
Longitudinal Observational Study of Human Adipose Tissue (LOSHAT)
The investigators will study the influence of initial fat cell size/number and adipose function (in particular lipolysis) on weight development over very long time periods (years).
By comparing investigations of fat biopsies or blood samples obtained at baseline, the investigators will determine the association between adipose morphology/function and changes in weight or development of metabolic complications (e.g.
metabolic syndrome, glucose intolerance, type 2 diabetes, dyslipidemia and hypertension).
研究概览
详细说明
The investigators will ask all subjects that have previously been examined at the investigators laboratory (from 1992 and forward) in studies of adipose tissue function if they are interested to participate in a new study.
Previously obtained results from examinations of adipose tissue, anthropometric measurements and blood samples will be used as baseline. In addition, saved blood samples and samples from old fat biopsies can be re-investigated in some cases.
The new investigation includes a questionnaire that the subjects can answer by mail or email. In addition, anthropometric measurements and blood pressure determination will be performed at a primary health care center and blood samples will be collected for analysis of fasting glucose, HbA1C and lipids.
Information regarding all previously investigated subjects will also be collected from several Swedish national patient registries such as the Patient Register, Prescribed Drug register and Cause-of Death register.
研究类型
观察性的
注册 (预期的)
1500
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Peter Arner, MD, PhD
- 电话号码：+468 58582342
- 邮箱：peter.arner@ki.se
研究联系人备份
- 姓名：Daniel P Andersson, MD, PhD
- 电话号码：+468 58580000
- 邮箱：daniel.p.andersson@ki.se
学习地点
-
-
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Stockholm、瑞典、14186
- 招聘中
- Karolinska University Hospital
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接触：
- Daniel P Andersson, MD, PhD
- 邮箱：daniel.p.andersson@ki.se
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Men and women previously examined at our laboratory
描述
Inclusion Criteria:
- Previously participated in examinations at the investigators laboratory and donated adipose tissue.
- Previously participated in examinations at the investigators laboratory and donated blood samples that can be used to estimate lipolysis with a formula.
Exclusion Criteria:
- Decline to participate after invitation.
- Severe Psychiatric disease.
- Type 1 Diabetes
- Participants that have undergone bariatric surgery will be exluded in the primary analysis but will be analyzed separately in a secondary analysis for all above mentioned outcomes.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body mass index
大体时间：2018 to 2022
|
Body weight (in kilogram) will be assessed with a regular scale.
Height will be measured with a tape measure (in centimeters).
Body mass index (BMI) will be calculated with the formula weight (kg) divided by height^2 (in meter).
Changes in BMI from baseline values will be analysed.
|
2018 to 2022
|
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Fasting glucose
大体时间：2018 to 2022
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Fasting plasma glucose will be assessed and divided into normal glucose (glucose < 6.1 mmol/L), impaired fasting glucose (glucose 6.1-6.9 mmol/L) or type 2 diabetes (glucose > 6.9 mmol/L).
|
2018 to 2022
|
|
Number of participants with metabolic syndrome
大体时间：2018 to 2022
|
Metabolic syndrome is defined according to International Diabetes Federation, Waist circumference ≥102 cm for men or ≥88 cm for women.
In addition to this 2 of the following; Raised triglycerides: > 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality; Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L) in males, < 50 mg/dL (1.29 mmol/L) in females, or specific treatment for this lipid abnormality; Raised blood pressure (BP): systolic BP > 130 or diastolic BP >85 mm Hg, or treatment of previously diagnosed hypertension; Raised fasting plasma glucose (FPG): >100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes.
Scores are 0-5.
≥ 3 is defined as metabolic syndrome.
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2018 to 2022
|
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Number of participants with type 2 Diabetes
大体时间：2018 to 2022
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Based on a diagnosis in the Swedish National Patient Register, or prescribed drugs for Type 2 diabetes in the Swedish National Prescribed Drug Register or direct information from the subject.
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2018 to 2022
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Number of participants with dyslipidemia
大体时间：2018 to 2022
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Based on a diagnosis in the Swedish National Patient Register, or prescribed drugs for dyslipidemia in the Swedish National Prescribed Drug Register, or direct information from the subject.
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2018 to 2022
|
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Number of participants with Hypertension
大体时间：2018 to 2022
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Based on a diagnosis in the Swedish National Patient Register, or prescribed drugs for hypertension in the Swedish National Prescribed Drug Register, or direct information from the subject.
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2018 to 2022
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Genetic variations linked to lipolysis
大体时间：2018 to 2022
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Genome-wide association study (GWAS) with focus on genes related to lipolysis and analysis of single nucleotide polymorphisms (SNPs).
Samples from baseline examination will be used in the analysis.
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2018 to 2022
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Peter Arner, MD, PhD、Karolinska University Hospital
- 研究主任：Daniel P Andersson, MD, PhD、Karolinska University Hospital
- 学习椅：Mikael Rydén, Md, PhD、Karolinska University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年9月20日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2023年12月31日
研究注册日期
首次提交
2018年8月23日
首先提交符合 QC 标准的
2018年9月14日
首次发布 (实际的)
2018年9月18日
研究记录更新
最后更新发布 (实际的)
2020年9月4日
上次提交的符合 QC 标准的更新
2020年9月2日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.