NCT00907075已完成不适用
Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus
Mondelēz International, Inc.3 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56).
研究概览
简要总结
The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-79 years of age, inclusive.
- •Diagnosis of type 2 diabetes, at least nine months prior to screening.
- •Stable use of oral hypoglycemic medication for at least two months prior to screening.
- •Body mass index (BMI) ≥25.0 and <45.0 kg/m2 at screening.
- •Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.
排除标准
- •History or diagnosis of type 1 diabetes mellitus.
- •Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
- •Weight loss or gain >10 lb (4.5 kg) in the two months prior to screening.
- •Abnormal laboratory test results of clinical importance.
- •History of gastrointestinal surgery for weight-reducing purposes.
- •Poorly controlled hypertension.
- •A clinically important medical or other condition.
- •Any major trauma or major surgical event within three months of screening.
- •Use of injected medications for glucose control within four weeks prior to screening.
- •Use of weight loss medications, supplements, programs, or meal replacement products within two months of screening.
- •Unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism.
- •Any history of extreme eating habits or an eating disorder diagnosed by a health professional.
- •Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.
结局指标
主要结局
Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56).
时间窗: 10 weeks
次要结局
- Change in 24 hour mean circulating glucose level from baseline to end of treatment.(10 weeks)
- Change in fasting plasma glucose and insulin from baseline to end of treatment.(10 weeks)
- Change in lipid parameters (Total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of treatment.(10 weeks)
- Change in dietary macronutrient composition from baseline to end of treatment.(10 weeks)
研究者
研究点 (3)
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