The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index
研究概览
简要总结
Like most endocrine axes, the entero-insular axis is expected to go through an age-related physiological deterioration, what might contribute to special features of the elderly onset type 2 diabetes in comparison to middle-age.
Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.
The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset type 2 diabetes.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable weight (< 5% variation) within the last three months
- •Age: 35 to 50 years old for middle-age group, and 65 to 80 years old for elderly group.
- •BMI: 20 to 29.9 kg/m2
- •Normal glucose tolerance (NGT) for groups Elderly and Middle-age
排除标准
- •Use of estrogen, progestogen or systemic corticosteroids.
- •Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity
- •Uncontrolled systemic or debilitating diseases
结局指标
主要结局
Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index
时间窗: within 1 month from screening visit
Insulin sensitivity index calculated as HOMA-IR = (Glucose \* Insulin) / 22.5, where glucose is mmol/L and insulin is mili-units (mU)/L. Higher values indicate lower insulin sensitivity.
Glucose Infusion Rate
时间窗: within 1 month from screening visit
Whole-body insulin sensitivity, as estimated by the mean glucose infusion rate corrected for fat-free mass(FFM){mg\*\[kg(FFM)\^-1\]\*min\*10} at last 60 min of 180-min hyperglycemic clamp
Adaptive Beta-cell Insulin Production. The Product of Meal Tolerance Test-derived Insulinogenic Index (IGI) for Clamp-derived Insulin Sensitivity Index (ISI) in Normoglycemic Subjects After 65 Years Old in Comparison With Middle-age Normoglycemic Subjects
时间窗: within 1 month from screening visit
Beta-cell function was determinated as the beta-cell secretion measured by meal tolerance test adjusted by insulin sensitivity assessed by the hyperglycemic clamp test:Insulinogenic Index/Insulin Sensitivity Index adjusted by free fat mass
Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.
时间窗: within 1 month from screening visit
Distinctive beta-cell function as measured by the disposition index - based on the acute insulin response from the arginine stimulation test versus glucose infusion rate adjusted by free fat mass from hyperglycemic clamp - in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects.
次要结局
- Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration(within 1 month from screening visit)
- GLP-1 Area Under the Curve (AUC)(1 month from screening visit)
研究者
Bruno Geloneze
Dr. Bruno Geloneze
University of Campinas, Brazil