Diabetic Foot Surgery Patients: What is Their Metabolic Profile and Are Nutritional Goals Met
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficiency of nutritional therapy: Dietary intake (food diary; in Kcal) compared to caloric need (indirect calorimetry; Kcal)
研究概览
简要总结
Prospective interventional follow-up of diabetic foot surgery patients, their metabolic/nutritional profile, and the nutritional adequacy in the perioperative setting.
Primary objective: to establish the preoperative metabolic profile of diabetic patients scheduled for foot surgery and determine the postoperative nutritional status. The daily values of caloric intake compared to caloric need and protein intake compared to protein need will be evaluated as primary endpoint. [Actual daily caloric and protein intake is compared to the calculated need.] These values will each be presented as relative %.
Wound healing is an anabolic process that requires ample access to nutrients. Insulin is considered the main anabolic hormone of the body, and regulates the metabolism of carbohydrates, fats and proteins. Diabetic patients lack this very hormone, and in addition are required to follow a strict dietary regime that further limits caloric and protein intake. Very little research had been done to evaluate the role of malnutrition in delayed wound healing.
Overall: What is the metabolic/nutritional profile of a diabetes patient with foot wounds undergoing surgery? Is the intake of proteins and caloric adequate in the perioperative setting and are nutritional goals met? Is there a possibility for iatrogenic malnutrition? What kind of nutrition would possibly be useful to optimize intake?
详细描述
Diabetes mellitus is an important risk factor for foot ulcers often leading to minor or even major amputations, all with functional impairment.
The pathophysiology of diabetic foot wounds is multifactorial, and a combination of treatment modalities is required to accomplish wound healing. As such, infection control (by means of surgery as well as antibiotics), off-loading and revascularization all contribute to a successful outcome.
Wound healing invariably requires some degree of tissue regeneration, which is an anabolic process that requires ample access to nutrients and energy. In spite of malnutrition being detrimental to wound healing, the nutritional status of the diabetic foot patient is rarely taken into account when devising up a treatment regimen. This is remarkable, as diabetic patients are prone to inadequate energy intake because of three important reasons.
First, they lack insulin, which is considered the main anabolic hormone of the body. Insulin regulates the uptake, storage and conversion of several crucial nutrients, like carbohydrates, fats and proteins, and plays such a pivotal role in energy house holding that diabetes affects almost all cellular processes in the body. Second, diabetic patients are invariably put on a dietary regime in order to maintain strict glycemia control. This requires a patient to schedule meals at very regularly timed intervals, of consistent caloric quantity. In addition, dietary intake has to be adapted to prior or scheduled physical exercise. The primary objective of a diabetes diet being glycemia control may consequently mean that it falls short as an optimal regimen for wound healing.
Third, diabetic foot patients that undergo surgery frequently deviate from their customary diet. Fasting is often mandatory for anesthesia, and is usually prolonged due to neuropathic gastroparesis. Antibiotics may interfere with gastro-intestinal uptake. Hypermetabolic stress due to infection or surgery may temporarily increase energy expenditures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18years
- •under oral or insulin therapy for diabetes mellitus
- •patient recruitment at the multidisciplinary at the diabetic wound clinic of the University Hospital Brussel
- •scheduled for surgery, with an indication related to the wound(s).
排除标准
- •Presence of other metabolic diseases (inborn/acquired such as hyperthyroidism)
- •Incapacity to undergo research investigations (relative CI to body composition measurement by Bio electrical impedance BIA: cardiac defibrillator)
- •Limb- or life threatening disease
- •Patient or relatives is/are unable to accurately record dietary intake
研究组 & 干预措施
Interventional group
Nutritional intake: these data will be evaluated daily during preoperative hospitalization, at home, and during the actual hospitalization, from surgical intervention to discharge. Before the follow-up consultation, patients will keep a food diary. The dieticians will calculate intake and need.
Metabolic data: body composition using BIA (Nutrilab Akern) and REE using indirect calorimetry (Cosmed Q NRG) will be analyzed in three timepoints: preoperative, postoperative and at follow-up consultation. This measurements take maximum ten minutes and do not cause discomfort to the participants.
干预措施: Metabolic profile and nutritional goals in diabetic foot surgery patients (Diagnostic Test)
结局指标
主要结局
Efficiency of nutritional therapy: Dietary intake (food diary; in Kcal) compared to caloric need (indirect calorimetry; Kcal)
时间窗: an average of 3 weeks (perioperative period)
Actual daily caloric and protein intake compared to the calculated need. These values will each be presented as relative %.
次要结局
- Caloric needs (indirect calorimetry; Kcal) in diabetic foot surgery(an average of 3 weeks (perioperative period))
- Evaluation of choice for oral nutritional supplements, enteral nutrition and parenteral nutrition (%)(an average of 3 weeks (perioperative period))
研究者
Elisabeth De Waele
Head of Clinics ICU
Universitair Ziekenhuis Brussel
