Inflammation and Insulin Resistance in Kidney Stone Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference in inflammatory markers between participants who form kidney stones and controls
研究概览
简要总结
This observational study aims to look at the connections between kidney stones, insulin resistance, and inflammation. The researchers hypothesize that people who form calcium kidney stones and have insulin resistance may have higher levels of inflammation because they have more visceral fat (fat around the abdominal organs).
The study will recruit 20 people who have had calcium kidney stones but don't have diabetes, and 20 healthy people who haven't had kidney stones. All the participants will come to the research center at the University of Chicago Medicine. Participants will have a dual-energy X-ray absorptiometry (DEXA) scan to measure their visceral fat, and give blood and urine samples. The blood will be tested for insulin resistance, inflammatory markers, and other metabolic factors. The urine will be analyzed for substances that increase kidney stone risk.
The main goal is to see if the kidney stone formers with insulin resistance have more visceral fat compared to those without insulin resistance and the healthy participants. The researchers will also compare inflammatory marker levels between groups, and look at how visceral fat, inflammatory markers, insulin resistance, and urine stone risk factors are related.
The findings may help explain how kidney stones are connected to metabolic conditions like diabetes and cardiovascular disease. Researchers hope this information will help identify stone formers at risk early and develop preventive treatments in the future.
详细描述
Participants will be recruited from the University of Chicago Medicine Kidney Stone Clinic (stone formers) and research participant registries (controls). After providing informed consent, participants will complete the following procedures:
Pre-Study:
- One week prior, participants will discontinue vitamin C, multivitamins, calcium supplements, and diuretics.
- One day prior, participants will complete a 24-hour urine collection and food frequency questionnaire at home.
Study Visit:
2. Participants will be admitted to the University of Chicago's Clinical Research Center (CRC) in a fasted state.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stone formers:
- •Age 18-70
- •History of at least one calcium-based kidney stone
- •Healthy Controls:
- •Age 18-70
- •No history of kidney stone or family history of kidney stones
排除标准
- •(for both groups):
- •History of primarily uric acid
- •Cysteine, or struvite stones
- •History of diabetes or impaired glucose tolerance
- •Previous thiazide use
- •Anyone on a medication that cannot be stopped that may affect urine composition
- •Previous bariatric surgery or ileostomy
- •Primary hyperparathyroidism and elevated serum calcium.
结局指标
主要结局
Difference in inflammatory markers between participants who form kidney stones and controls
时间窗: 1 week total, one half day in the CRC
Markers of systemic inflammation, including high-sensitivity CRP, interleukin-6, MMP-7, MMP-9, TNF-alpha, and endotrophin.
Difference in visceral fat content in participants who form kidney stones with insulin resistance compared to participants who form kidney stones without insulin resistance and controls
时间窗: 1 week total, one half day in the CRC
Levels of visceral fat as measured by dual x-ray absorptiometry (DEXA).
次要结局
- Correlation between visceral fat and inflammatory markers(1 week total, one half day in the CRC)
- Differences in visceral fat levels(1 week total, one half day in the CRC)
- Differences in insulin resistance between kidney stone patients and controls(Time Frame: 1 week total, one half day in the CRC)
- Differences in urine composition(1 week total, one half day in the CRC)
- Differences in markers of systemic inflammation between kidney stone patients and controls(Time Frame: 1 week total, one half day in the CRC)