Exploration of the Weight Neutral Effects of Insulin Detemir Compared to Insulin Glargine: A Measure of Satiety and Calories Consumed in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Calories Consumed After Fast.
研究概览
简要总结
Patients with diabetes treated with insulin often gain weight, which may deter patients from adhering to insulin treatment. Detemir is one type of long acting insulin approved by the Food and Drug Administration for use in people with diabetes. It is similar to other long acting insulins (Neutral Protein Hagedorn [NPH], glargine) except that it has been associated with less weight gain compared to other types of insulin. The reasons for this are still unclear. One possibility is that detemir insulin acts differently than do other insulins in affecting how diabetic patients eat meals. The purpose of this study is to determine whether appetite and calories eaten during a meal are affected by the type of insulin used to treat diabetes. This is a pilot study which means we are gathering preliminary information to determine if a larger study can be done.
详细描述
Insulin detemir is a neutral, soluble long acting insulin analog with weight neutral properties. In limited studies, it has been shown to result in less weight gain in type 1 and type 2 diabetics compared with other long acting insulin formations. A possible mechanism for its weight neutrality is the fatty acid chain that may allow for improved central nervous system activity and effects on satiety. The primary objective of this study is to determine if patients with type 1 diabetes consume fewer calories when allowed to eat to satiety while treated with insulin detemir compared to insulin glargine. Secondary objectives are 1) subject responses on validated satiety scales and food diaries, 2) bioelectrical impedance analysis, 3) resting energy expenditure on indirect calorimetry/metabolic cart measurement, and 4) centrally acting mediators of satiety measured in the serum (Peptide YY [PYY], ghrelin, leptin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Treated with long-acting and meal time insulin therapy for at least 2 years
- •Ages 18 to 60 years of age
- •Glycosylated hemoglobin value between 7 - 9 mg/dL
- •C-peptide value less than 1.0 pmol/ml 90 minutes after oral Boost Plus administration.
排除标准
- •Advanced complications of diabetes (nephropathy, retinopathy, significant neuropathy, coronary artery disease)
- •Severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure
- •Pregnancy
- •Alcohol or drug abuse or dependence within three months of study entry
- •Less than 50 % agreement on 50-item Food Questionnaire with the Food Array "buffet style" study meal.
- •Women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.
研究组 & 干预措施
Insulin Detemir
Insulin Detemir
干预措施: Insulin Detemir (Drug)
Insulin Glargine
Insulin Glargine
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Calories Consumed After Fast.
时间窗: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks
Total energy ingested following the 24 hour fast.
次要结局
未报告次要终点