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临床试验/NCT03159494
NCT03159494已完成不适用

A Self-monitoring Approach in Evaluating the Effect of 3 Weeks of High-Intense Interval Training in Type 2 Diabetics

University College of Northern Denmark0 个研究点目标入组 16 人开始时间: 2014年2月14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
发起方
入组人数
16
主要终点
Fat percent

研究概览

简要总结

10 patients with type 2 diabetes participated in a training-intervention consisting of 8 times of High-Intensity Training (HIT). Before and after the intervention the patients were tested regarding Oral Glucose Tolerance Test, blood pressure, weight and fat% and VO2max. A pilot study was conducted with 6 patients with type 2 diabetes using the same protocol but only 6 times of training.

详细描述

The aim of the study is to investigate to which extent a short period of HIT can improve cardio-metabolic status measured by simple methods such as OGTT (fasting glucose and 2h-glucose), blood pressure, weight and fat percent in patients with type 2 diabetes

Protocol:

At day -2 a VO2max test was performed in order to get familiarized to the test before the actual test at day 0. The pretest at day 0 was carried out at least two days before the first training session in order to allow patients to recover after the Vo2max test before training. After 8 times of training the posttest was accomplished at day 21 two days after the last training session in order to avoid the acute effect of training. Both pre- and posttest were carried out on Fridays and training days were Mondays, Wednesdays and Fridays.

The pre- and posttest contained the following: Oral glucose tolerance test (OGTT), blood pressure measurement, weight and fat% measurements and VO2maxtest. Pretesting also contained a questionnaire about physical activity and their medical history in addition to the physiological tests.

Oral Glucose Tolerance Test (OGTT): Participants were instructed to continue a normal diet in the days leading up to the test. At the day of testing they should meet fasting (for at least 10 hours) and they were asked not to take any medications that could influence blood glucose levels in the fasting hours (two forgot and they were instructed also to take medications prior to the posttest). At baseline a small blood sample was collected by the use of a finger prick to determine fasting capillary blood glucose level (producent). The fingertip was disinfected before the finger prick and the first drop of blood was removed before applying a drop of blood in the glucose meter. The participants were then instructed to drink 75 mg of glucose dissolved in 300 ml of water. Blood samples were collected after 30, 60, 90 and 120 minutes with the use of finger prick.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed type 2 diabetes
  • Approved to participate by own general practitioner

排除标准

  • Conditions contraindicating training at high intensity

研究组 & 干预措施

Intervention group

Experimental

10 patients with type 2 diabetes enrolled to perform 8 times of High-Intensity Training. The subjects were tested before and after the training period.

干预措施: High-Intensity Training (Other)

Pilot study

Experimental

6 patients with type 2 diabetes enrolled to perform 6 times of High-Intensity Training. The subjects were tested before and after the training period

干预措施: High-Intensity Training (Other)

结局指标

主要结局

Fat percent

时间窗: Through study completion, an average of 3 weeks

A Tanita digital scale with bioelectric impedance was used to measured fat percent (%)

Fasting glucose concentration

时间窗: Through study completion, an average of 3 weeks

A small blood sample was collected by the use of a finger prick to determine fasting capillary blood glucose level (mmol/l) by a glucose meter (Accu Check)

2-hour glucose concentration

时间窗: Through study completion, an average of 3 weeks

The participants were instructed to drink 75 mg of glucose dissolved in 300 ml of water. Blood samples were collected after 30, 60, 90 and 120 minutes with the use of finger prick and blood concentrations were measured by a glucose meter (Accu Check)

Weight

时间窗: Through study completion, an average of 3 weeks

Weight measured i kilograms on a Tanita digital scale without shoes

Blood pressure

时间窗: Through study completion, an average of 3 weeks

Blood pressure was measured after 10 min of rest in a sitting position. An automatic blood pressure monitor was used and three measures were made. The lowest of the three values were used in calculations.

Oxygen consumption

时间窗: Through study completion, an average of 3 weeks

Bicycle test on a Lode ergometer bike to exhaustion with direct measurement of oxygen consumption by Breath-by-breath on Masterscreen CPX. The participants were instructed about the protocol before applying the equipment used for the test. Then there was a warm-up for 5 min. on 50-75 watt followed by incremental increase in intensity by 25 watt each minute until exhaustion. The outcome was measured in l/min and ml/kg/min

Training intensity

时间窗: Through study completion, an average of 3 weeks

The training intensity measured i % of max heart rate and Borg´s rate of perceived exhaustion was made for each interval (10 intervals/training, 8 times of training)

次要结局

  • Physical acitity(At baseline)

研究者

发起方
University College of Northern Denmark
申办方类型
Other
责任方
Sponsor

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