GLP-1 receptor agonists as preventive treatment of diabetes after renal transplantation: a single-arm interventional clinical trial. Study 2: Patients on the waiting list for kidney transplantation.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of patients with reversal of metabolic syndrome after 3 and 6 months of GLP1RA initiation defined by correction of metabolic syndrome (must be reduced to 1 or less defining criteria) by: (a) correction of pre-diabetes as determined by: fasting plasma glucose of 100-126 mg/dL (5.6-6.9 mmol/L), and/or impaired fasting glucose of <126 mg/dL (7 mmol/L) with 2 h plasma glucose after an oral glucose of 140-200 mg/dL (7.8-11 mmol/L)
研究概览
简要总结
To evaluate whether 3 to 6 months treatment with GLP-1 RA in patients on the RT waiting list with metabolic syndrome (defined by meeting 2 or more criteria of: prediabetes, abdominal obesity, hypertriglyceridemia and/or dyslipidemia) reverse metabolic syndrome before RT - evaluating the status after 3 and 6 months after having started the medication - (reversing the metabolic syndrome) after 3 and, if possible, 6 months of treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients on the RT waiting list
- •Over 18 years
- •Women of childbearing potential must use effective contraceptive measures during their participation in the study.
- •With metabolic syndrome defined by 2 or more of the following criteria (National Cholesterol Education Program Adult Treatment Panel III guidelines (7) adjusted for: (a) pre-diabetes as determined by: fasting plasma glucose of 100-126 mg/dL (5.6-6.9 mmol/L ), and/or impaired fasting glucose <126 mg/dL (7 mmol/L) with 2 h plasma glucose after an oral glucose of 140-200 mg/dL (7.8-11 mmol/L) and/or HbA1c 5.7-6.4%) (b) obesity as defined by: waist circumference greater than 102 cm (men) or 88 cm (women) c) triglycerides ≥150 mg/dL d) HDL cholesterol < 40mg/dL in men or < 50mg/dL in women
排除标准
- •Under 18 years of age,
- •previously diagnosed diabetes,
- •Hepatic Failure
- •history of pancreatitis (acute or chronic),
- •síndrome de neoplasia endocrina múltiple tipo 2 (MEN 2)
- •personal or family history of medullary thyroid carcinoma (MTC),
- •pregnant or lactating women
- •moderate to severe pre-existing gastroparesis.
结局指标
主要结局
Proportion of patients with reversal of metabolic syndrome after 3 and 6 months of GLP1RA initiation defined by correction of metabolic syndrome (must be reduced to 1 or less defining criteria) by: (a) correction of pre-diabetes as determined by: fasting plasma glucose of 100-126 mg/dL (5.6-6.9 mmol/L), and/or impaired fasting glucose of <126 mg/dL (7 mmol/L) with 2 h plasma glucose after an oral glucose of 140-200 mg/dL (7.8-11 mmol/L)
Proportion of patients with reversal of metabolic syndrome after 3 and 6 months of GLP1RA initiation defined by correction of metabolic syndrome (must be reduced to 1 or less defining criteria) by: (a) correction of pre-diabetes as determined by: fasting plasma glucose of 100-126 mg/dL (5.6-6.9 mmol/L), and/or impaired fasting glucose of <126 mg/dL (7 mmol/L) with 2 h plasma glucose after an oral glucose of 140-200 mg/dL (7.8-11 mmol/L)
次要结局
- Insulin sensitivity as measured by assessment of the homeostatic model calculated for insulin resistance score (HOMA-IR) and β-cell function as measured by the HOMA index of β-cell function (HOMA-B) at study inclusion, 3 and 6 months after initiation of therapy.
- Adverse Reactions: Gastrointestinal (nausea or diarrhea), pancreatitis, headaches, injection site pain, weakness, and severe hypoglycemic episodes defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective measures), rate of treatment discontinuation at 3 and 6 months after initiation of therapy.
- Changes in abdominal obesity (waist circumference and change in waist-hip ratio since enrollment in the study, at 3 and 6 months after the start of therapy).
- Rate of treatment interruptions
研究者
Núria Montero
Scientific
Bellvitge University Hospital