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临床试验/NCT03970135
NCT03970135已完成不适用

Fedt og Sukkerstofskiftet Under Faste Hos Patienter Med Lav Muskelmasse.

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Change in fat metabolisms from fed to fasted state

研究概览

简要总结

In a study from 2003 the investigators showed that adult patients with very low skeletal muscle mass (spinal muscular atrophy (SMA) type II, Duchenne muscular dystrophy, congenital muscular dystrophy) are prone to develop hypoglycemia during prolonged fasting. Since then case reports have described the same phenomenon with hypoglycemia and metabolic crises in children with low skeletal muscle mass provoked by infection, fasting and surgery. Pathophysiological mechanisms of metabolism have never been investigated in adults or children with SMA II. Thus the investigators studied fat and glucose metabolism during prolonged fasting in patients with SMA II and LAMA 2 and compared results to those found in healthy controls.

详细描述

Design. This is a prospective case-control study investigating fat and glucose metabolism in patients with low muscle mass during prolonged fasting, comparing results to those found in healthy controls.

Setting. All children were admitted to the Department of Pediatrics and Adolescents medicine, Rigshospitalet, and all adult subjects were admitted to the Department of Neurology, Rigshospitalet at 4 pm for a 24-hour fasting period.

Protocol. The protocol consisted of two visits. A pre-experimental visit and a study visit.

Pre-experimental visit. Total muscle mass presented as lean body mass (LBM) was measured by DEXA scan. Furthermore, pre-experimental preparations included that all subjects were instructed to follow national nutritional recommendations with a healthy diet consisting of less than 30% fat, low fat protein, long chain carbohydrates and minimize sugar intake three days before the study.

Study visit. Patients were admitted to the hospital at 16:00 hours for IV catheter placement and a standardized evening meal at 17:00. Two venous catheters were inserted, one in the cubital vein (for stable-isotope infusion) and one in the distal cephalic vein (for blood sampling). A heating pad, covering the hand and distal forearm, ensured shunting of arterial blood to the veins in order to obtain arterialized blood. A primed, constant rate infusion of [U-13C]-palmitate (0.0026 mg kg-1 min-1, primed by a 0.085 mg kg-1 NaH13CO3 bolus) and [D2]-glucose (0.0728 mg kg-1 min-1, primed by a 3.203 mg kg-1 D2- glucose bolus) was delivered by a Gemini PC2 pump (IMED, San Diego, CA). Preparation of tracers and tracer calculations were performed as described.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
1 Year 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with low skeletal muscle mass

排除标准

  • Competing disorders interfering with interpretation of results
  • Medication that will interfere with results
  • Compliance problems
  • Participation in other clinical trials that will interfere with interpretation of results
  • Pregnancy or breastfeeding

研究组 & 干预措施

Fasting

Experimental

干预措施: Fasting (Other)

结局指标

主要结局

Change in fat metabolisms from fed to fasted state

时间窗: 24 hours

Using indirect calorimetri and stable isotope technique: of \[U-13C\]-palmitate (0.0026 mg kg-1 min-1, primed by a 0.085 mg kg-1 NaH13CO3 bolus) fat metabolism was measured at fed state and during 24 hours of fasting

Change in carbohydrates metabolisms from fed to fasted state

时间窗: 24 hours

Using indirect calorimetri and stable isotope technique: of \[D2\]-glucose (0.0728 mg kg-1 min-1, primed by a 3.203 mg kg-1 D2- glucose bolus) glucose metabolism was measured at fed state and during 24 hours of fasting

次要结局

  • Change in insulin, glucagon, epinephrine and norepinephrine and the metabolites palmitate, free fatty acids (FFA), glycerol, glucose, pyruvate, β-hydroxybuturate, acetoacetate from fed to fasted state.(24 hours)
  • Change in palmitate from fed to fasted state.(24 hours)
  • Change in glycerol from fed to fasted state.(24 hours)
  • Change in glucose from fed to fasted state.(24 hours)
  • Change in glucagon from fed to fasted state.(24 hours)
  • Change in norepinephrine from fed to fasted state.(24 hours)
  • Change in epinephrine from fed to fasted state.(24 hours)
  • Change in pyruvate from fed to fasted state.(24 hours)
  • Change in β-hydroxybuturate from fed to fasted state.(24 hours)
  • Change in acetoacetate from fed to fasted state.(24 hours)
  • Change in free fatty acids (FFA) from fed to fasted state.(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Cathrine Oerngreen

PI

Rigshospitalet, Denmark

研究点 (2)

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