Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Beta-cell Function - C-peptide AUC (Area Under the Curve)
研究概览
简要总结
The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.
详细描述
This is a 72 months long randomized clinical trial longitudinally evaluating beta-cell function, as well as glycemic control and inflammatory markers in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus diagnosed within the prior 2 months
- •HbA1c > 7% at the time of inclusion
- •willing to perform intensive diabetes management
- •able to comply with treatment and follow-up regimen
排除标准
- •HbA1c > 8% at time of randomization
- •creatinine > 1.5 mg/dl
- •liver function tests > 3 times the upper limit of normal
- •severe anemia
- •severe proliferative retinopathy
- •NYHA class III or IV heart failure
- •active CAD or recent (within 6 months) MI
- •pregnant, willing to get pregnant, or not willing to practice any contraceptive method
- •non-english speaking
- •active heavy alcohol or illicit drug users (within past 6 months)
- •history of lactic acidosis
研究组 & 干预措施
Metfomin and Insulin
Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration
干预措施: Metformin (Drug)
Metfomin and Insulin
Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration
干预措施: Insulin (Drug)
Metformin, Pioglitazone and Glyburide
Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
干预措施: Metfomin (Drug)
Metformin, Pioglitazone and Glyburide
Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
干预措施: Pioglitazone (Drug)
Metformin, Pioglitazone and Glyburide
Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
干预措施: glyburide (Drug)
结局指标
主要结局
Beta-cell Function - C-peptide AUC (Area Under the Curve)
时间窗: 72 months
C-peptide AUC during a 3-hours mixed meal challenge testing
次要结局
- Insulin Sensitivity as Measure be Matsuda Index(72 months)
- Bet-cell Function Measured by Disposition Index(72 months)
- Inflammatory Markers - PAI-1(72 months)
- Inflammatory Markers - hsCRP(72 months)
- Quality of Life Survey (QoL) - Hypoglycemia Fear(72 months)
- Weight(72 months)
- Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment(72 months)
- Inflammatory Markers -Fibrinogen(72 months)
- Quality of Life Survey (QoL) - Treatment Satisfaction(72 months)
- Quality of Life Survey (QoL) - Treatment Impact(72 months)
- Quality of Life Survey (QoL) - Glycemia Control Perception(72 months)
- Quality of Life Survey (QoL) - Social Stigma(72 months)
- Quality of Life Survey (QoL) - Current Health Perception(72 months)
- Quality of Life Survey (QoL) - Social or Vocational Worry(72 months)
- Quality of Life Survey (QoL) - Lifestyle Flexibility(72 months)
- Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment(72 months)
研究者
Ildiko Lingvay
MD, MPH, MSCS
University of Texas Southwestern Medical Center