Effect of Supplementation With b- Hydroxy Methyl Butyrate and Glutamine in Wound Healing Histology in Type 2 Diabetes and Controls Bloody Areas
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Wound healing:Number of cells per clauster in tissue sample of wound.
研究概览
简要总结
A randomized controlled clinical trial in two groups of supplementation with HMB and glutamine. Each group consist in 25 patients with bloody areas, one group will receive and intervention with HMB and Glutamine and the other will receive a placebo with calcium caseinate.
详细描述
A fundamental part of the integral management of wound healing in patients with bloody areas is nutrition, since it involves biochemical events that depend on the substrates it provides. Wound healing is a phase that demands higher needs of energy-protein than the requirement. Problem statement: Poor nutrition decreases, through specific phases, normal processes that allow the progression of wound healing. Nutrient deficiencies can have negative effects on wound healing by prolonging the inflammatory phase, decreasing fibroblast proliferation, and modifying collagen synthesis. Some amino acids are essential for the process, such as Glutamine and Hydroxymethylbutyrate.
Objective
To evaluate the effect of Glutamine and Hydroxymethylbutyrate supplementation over the cells involved in wound healing of bloody areas. Hypothesis: Glutamine and Hydroxymethylbutyrate supplementation promotes a positive effect over the cells involved in wound healing of bloody areas. Methodology: A randomized controlled clinical trial, in patients with diagnosis of bloody areas. They will be divided into two groups, the first will receive an intervention with Glutamine (14g) and Hydroxymethylbutyrate (3g) and a control group will receive a placebo with calcium caseinate (17g)
A sample of the affected tissue will be taken before and after the supplementation where histology will be analyzed.
Remains of tissue will be obteined during surgery wash for histology.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bloody areas at hospital admission
- •Hospital length stay around 15 days
- •Medical treatment with surgical washing and negative pressure systems
- •For the groups with diabetes, patients with diagnosis of type 2 diabetes with bloody areas.
- •Patients that accepts and signs the informative consent.
排除标准
- •patients with cancer or immunodeficiency
- •patients with HbA1c < 12
- •patients with collagen disease
- •patients with allergy to intervention substances (HMB, glutamine)
研究组 & 干预措施
HMB and glutamine supplementation
Patients with type 2 diabetes with supplementation HMB 3g, powder once a day and glutamine powder 14g once a day supplementation during 15 days.
干预措施: glutamine supplementation (Drug)
HMB and glutamine supplementation
Patients with type 2 diabetes with supplementation HMB 3g, powder once a day and glutamine powder 14g once a day supplementation during 15 days.
干预措施: HMB (Drug)
placebo patients
Patients with type 2 diabetes with placebo( calcium caseinate) supplementation during 15 days 17g of powder once a day
干预措施: Placebo (Drug)
结局指标
主要结局
Wound healing:Number of cells per clauster in tissue sample of wound.
时间窗: 15 days
To evaluate the effect of supplementation in cellular differentiation. It will be counted and compared the number of cells per cluster in a tissue sample (lymphocytes, fibroblasts , macrophages and angiogeny) at the begining and after the supplementation.
次要结局
未报告次要终点
研究者
Dr. Vanessa Fuchs Tarlovsky
Head of clinical nutrition
Hospital General de Mexico