Regional Adipose Tissue Characteristics in Type II Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Immune Cell Quantification
研究概览
简要总结
Fat tissue in different parts of the body has different characteristics. Several studies have associated abdominal fat to an increased risk for multiple metabolic diseases, such as type 2 diabetes and cardiovascular disease, compared with fat located under the skin at the hips and thighs. However, the investigators do not know how the abdominal fat causes or contributes to the development of these diseases or how the development of these disease may in turn cause or contribute to changes in the fat tissue. The general objective of this study is to understand these mechanisms.
To investigate these questions, the study will recruit 140 participants, both men and women aged 18-65 years. The participants will be divided into three groups: 40 people with obesity, 40 with diabetes, and 60 lean individuals. Participants will be recruited from patients at the CIUSSS du Nord-de-l'Île-de Montréal - Hôpital du Sacré-Coeur de Montréal who are awaiting bariatric or general abdominal surgery, as well as from the general population in the Montreal area.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men, premenopausal and postmenopausal females between 18-65 years
- •Anticipating having bariatric surgery (participants with obesity) or general surgery in the abdominal area (normal weight participants) with a duration of less than 1.5 hours.
- •BMI 30 kg / m2 (participants with obesity)
- •Weight Stable for a minimum of two months prior to the first pre-op visit
排除标准
- •Renal impairment defined by creatinine clearance; 60 ml/minute
- •Uncontrolled hypothyroidism
- •No comorbidity other than diabetes type II Exceptions: controlled hypertension, hypothyroidism controlled, controlled dyslipidemia
- •Use prescribed medication that affect our outcomes E.g. Exceptions include metformin, DPP-4 inhibitors, inhibitors of the α-glucosidase, hypotensive with a stable dose for 3 months lipid lowering with a stable dose for 3 months.
结局指标
主要结局
Immune Cell Quantification
时间窗: 5 years
Flow Cytometry will be used to quantify immune cells in the fat tissue.
Pre-adipocytes and adipocyte characteristics
时间窗: 5 years
Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.
Blood Inflammatory Markers
时间窗: 5 years
The inflammatory cytokines (e.g. IL6, TNFα), chemokines (e.g. monocyte chemoattractant protein-1), genomics, and adipokines (e.g. leptin, adiponectin) in blood and adipose tissue via PCR, luminex or ELISA will be measured
次要结局
未报告次要终点
研究者
Sylvia Santosa
Professor
Concordia University, Montreal