Adipose Tissue Metabolism in Obesity and Diet-Induced Weight Loss: A Prospective Observational Study of Body Weight, Fat Distribution, and Tissue-Specific Metabolic Adaptations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Percent Total Body Weight Loss (%TWL)
研究概览
简要总结
This prospective observational study investigates weight loss and metabolic changes in adults with obesity undergoing standard clinical diet-induced lifestyle treatment and counseling. Participants follow a very-low-calorie diet followed by a conventional weight loss diet in addition to lifestyle counseling and are followed for 12 months. The study examines weight loss as the primary outcome and characterizes changes in body composition, fat distribution, glucose metabolism, inflammation, and adipose tissue biology as secondary outcomes.
详细描述
Obesity is associated with metabolic complications including insulin resistance, fatty liver disease, dyslipidaemia, and systemic inflammation. Weight loss can improve these complications, yet individuals vary widely in weight loss, fat distribution and metabolic response. Subcutaneous adipose tissue dysfunction, including impaired mitochondrial biogenesis and increased inflammation, is thought to play a central role.
This prospective observational study follows adults with obesity undergoing standard-of-care diet and lifestyle treatment at Helsinki University Central Hospital, Helsinki, Finland. The intervention consists of a very-low-calorie diet for approximately 10 weeks, followed by gradual transition to a conventional weight loss diet and multidisciplinary clinical follow-up.
Assessments are performed at baseline, 6 months, and 12 months and include anthropometry, body composition (BIA, DXA), fasting blood samples, and oral glucose tolerance testing. Subcutaneous adipose tissue biopsies are obtained from four anatomical depots (gluteal, abdominal, breast, and upper arm) for molecular, mitochondrial, epigenetic, and histological analyses.
The primary outcome is diet-induced weight loss over 12 months. Secondary outcomes include changes in fat distribution, insulin sensitivity, lipid profile, inflammation, mitochondrial measures in adipose tissue, and depot-specific adipose tissue characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •BMI ≥28 kg/m²
- •Seeking treatment for obesity at Helsinki University Central Hospital or affiliated units
排除标准
- •Pregnancy or lactation
- •Current smoking
- •Anemia (Hb <130 g/L in men; <120 g/L in women)
- •Severe comorbid disease or condition judged by investigator to compromise safety
- •Contraindications to MRI (e.g., metal implants, claustrophobia)
研究组 & 干预措施
Diet-Induced Weight Loss Cohort
Adults with obesity undergoing standard clinical diet treatment including a very-low-calorie diet followed by transition to a conventional weight loss diet and lifestyle counseling
干预措施: Diet-Induced Weight Loss Program (Behavioral)
结局指标
主要结局
Percent Total Body Weight Loss (%TWL)
时间窗: Baseline to 6 months
Percentage change in body weight from baseline, calculated as 100 × (baseline weight - follow-up weight) / baseline weight
次要结局
- Change in Body Weight (kg)(Baseline to 6 and to 12 months)
- Change in Total Body Fat Mass (kg)(Baseline to 6 months and to 12 months)
- Change in Body Fat percentage (%)(Baseline to 6 and to 12 months)
- Change in Plasma Glycated Hemoglobin (HbA1c)(Baseline to 6 months and to 12 months)
- Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)(Baseline to 6 and to 12 months)
- Change in Plasma Total Cholesterol (mmol/L)(Baseline to 6 months and to 12 months)
- Change in Plasma LDL Cholesterol (mmol/L)(Baseline to 6 months and to 12 months)
- Change in Plasma HDL Cholesterol (mmol/L)(Baseline to 6 months and to 12 months)
- Change in Plasma Triglycerides (mmol/L)(Baseline to 6 months and to 12 months)
- Change in Plasma C-Reactive Protein Concentration (mg/L)(Baseline, to 6 months and to 12 months)
- Change in Mitochondrial DNA amount in Subcutaneous Abdominal Adipose Tissue(Baseline to 6 months and to 12 months)
- Change in Mitochondrial DNA amount in Subcutaneous Breast Adipose Tissue(Baseline to 6 months and to 12 months)
- Change in Mitochondrial DNA amount in Subcutaneous Upper Arm Adipose Tissue(Baseline to 6 months and to 12 months)
- Change in Mitochondrial DNA amount in Subcutaneous Lateral Upper Thigh Adipose Tissue(Baseline to 6 months and to 12 months)
研究者
Sini Heinonen
Docent in Experimental Internal Medicine
University of Helsinki