Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Difference in change in body weight of the intervention groups
研究概览
简要总结
The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA, might be useful in combination with diabetes medication. Some studies show that CLA can modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce body weight and body fat without interfering with the diabetes medications' effects on blood sugar.
详细描述
The long term goal of this research is to develop effective complementary strategies to aid in the management of type 2 diabetes (T2DM). Our central hypothesis is that CLA reduces body weight and body fat mass when administered concomitantly with oral diabetes medication, The rationale of this study is that using CLA to reduce body weight and body fat in people with T2DM may improve efficacy and longevity of the oral diabetes medications in the management of T2DM. We plan to test our central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims.
Specific Aim 1: Determine the ability of CLA to reduce body weight and body fat mass in people using oral diabetes medication for management of T2DM.
Specific Aim 2: Determine the ability of CLA to modulate insulin sensitivity when combined with oral diabetes medication.
Specific Aim 3: Determine the safety and tolerability of CLA in combination with oral diabetes medication.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus
- •HbA1c ≤ 9%
- •Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 45 kg/m2)
- •Age ≥ 30 and ≤ 70 years (postmenopausal if female)
- •Stable medical therapy for past 3 months
- •Stable body weight (within ± 2 kg) for past 3 months
- •Plans to remain in the Columbus, OH metropolitan area for at least 1 year
排除标准
- •Substance abuse
- •Current use of prescription or over-the-counter medications or supplements known to affect body composition
- •Current use of prescription or over-the-counter medications or supplements known to interact with thiazolidinediones(TZDs)
- •Current or previous diagnosis of congestive heart failure
- •Self-report of claustrophobia
- •Abnormal liver function
- •Impaired cognitive function
- •Current or previous diagnosis of renal disease
- •Gastrointestinal diseases or disorders
- •Current use of hormone therapies, or use within the past 3 months
- •Discontinuation of diabetes medication
研究组 & 干预措施
0 g CLA
Avandia (Rosiglitazone) 4-8mg/day OR other diabetes medication currently prescribed to participant, 0 g CLA, 8 g Placebo oil (based on typical American diet)
干预措施: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant (Drug)
3.2 g CLA
Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 3.2 g CLA, 4.8 g placebo oil (based on typical American diet)
干预措施: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant (Drug)
3.2 g CLA
Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 3.2 g CLA, 4.8 g placebo oil (based on typical American diet)
干预措施: conjugated linoleic acid (CLA) (Dietary Supplement)
6.4 g CLA
Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 6.4 g CLA, 1.6 g placebo oil (based on typical American diet)
干预措施: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant (Drug)
6.4 g CLA
Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 6.4 g CLA, 1.6 g placebo oil (based on typical American diet)
干预措施: conjugated linoleic acid (CLA) (Dietary Supplement)
结局指标
主要结局
Difference in change in body weight of the intervention groups
时间窗: Between baseline and week 32, or end of study
次要结局
- Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)(Weeks -4, -1, 0, 8, 16, 24, 31, 32)
- BNP (brain type natriuretic peptide)(Weeks -4 and 32)
- Appetite (as measured by appetite rating scale)(Weeks -4, 0, 16, 32)
- EKG(Weeks -4, 16, 32)
- Change in lipid profile (TChol, LDL, HDL, C-reactive protein)(Weeks -4, -1, 0, 8, 16, 24, 31, 32)
- Changes in liver enzymes (ALT and AST)(Weeks -4, -1, 0, 8, 16, 24, 31, 32)
- Change in bone density, bone formation and resorption markers(Weeks -4, -1, 31)
- Change in C-Peptide(Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32)
- Change in fat mass(Between baseline and week 32)
- Chronic stress (as measured by questionnaire)(Weeks -4 and 32)
- Energy balance (physical activity recalls, food records, indirect calorimetry)(Weeks -1, 16, 31)
- Change in lean mass(Between baseline and week 32)
- Change in insulin sensitivity(Between week 0 and week 32)
- Edema(Weeks -4, -1, 0, 8, 16, 24, 31, 32)
- Diabetes coping behaviors and self-efficacy(Weeks -4, -1, 32)
- Compliance (fatty acid composition, pill counts)(Weeks -1, 0, 8, 16, 24, 31, 32)
- Change in glucose control(Weeks -1, 16, 31)
- Nutrition knowledge(Weeks -4, 0, 32)
研究者
Martha Belury
Associate Professor
Ohio State University