Individual Responses in Insulin Sensitivity to Different Exercise Modalities in Persons With Overweight: a Randomized Cross-over Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 24 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
研究概览
简要总结
The aim of this randomized cross-over study is to collect information for the design of a precision exercise therapy cohort that will predict what modality of physical activity a physically inactive individual with overweight should perform to increase insulin sensitivity given their unique biology, environment, and context.
详细描述
This pilot study is needed prior to launching precision therapeutics programs, with the purpose to decrease the risk of research waste, increase the reliability of the experimental tests and estimate adequate sample size.
25 participants will be recruited to undergo three sets of experiments. An experiment consists of one exercise bout followed by an assessment of whole-body insulin sensitivity (measured from a oral glucose tolerance test) 1 and 2 days following the completion of the exercise bout yielding 19 study days of 3 hours each across 7 weeks, including the baseline measurement. The exercise modalities include 1) continuous aerobic exercise, 2) high intensity exercise and 3) resistance exercise training. A set consists of test-retest of the same experiment.
The objectives of this pilot study are
- to assess the longevity of the increased whole-body insulin sensitivity in the days following different exercise modalities
- To estimate the intra-individual differences of different exercise modalities on whole-body insulin sensitivity the days following the last exercise bout
- To assess the fidelity of the test- and exercise protocols
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be randomly allocated, following successful completion of the baseline measurements. An independent statistician generates a computer-generated randomization schedule including six possible sequence orders using balanced blocks, stratified by sex.
The schedule will be forwarded to a secretary not involved in any study procedures and will be stored on a password-protected computer. Sequentially numbered (according to the sequence) opaque, sealed envelopes will be prepared and stored in a locked cabinet in an access restricted room. The envelopes will be lined with aluminum foil to render the envelope impermeable to light. Following the baseline measurements, a study nurse, not involved with any study procedures, will open the envelope, and inform the researcher about the order. The participant be informed about the trial condition upon arrival to lab for the experiments (i.e. on the first morning of each set of trial conditions).
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age> 40 years
- •Inactivity, defined as < 1,5 hours of structured physical activity pr. week at moderate intensity and cycling < 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)
排除标准
- •• HbA1c>53 mmol/mol
- •Uncontrolled hypertension
- •Uncontrolled hyperlipidemia,
- •Known hyperthyroid disease
- •Endocrine disorders causing obesity
- •Known autoimmune disease
- •Unstable cardiovascular disease
- •Glucose lowering medications except for low dose metformin (=<1000 mg/day)
- •Current treatment with anti-inflammatory medication, unless pain killers without prescription
- •No participation in other research intervention studies
- •Pregnancy/considering pregnancy within the study period
- •Conditions countering exercise
结局指标
主要结局
24 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
时间窗: 6 weeks
Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 24 hours following the exercise bout
24 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
时间窗: 6 weeks
Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 24 hours following the exercise bout
次要结局
- 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
- 24 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
- 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
- 24 to 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
- 24 to 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
- Variation in insulin sensitivity (Oral glucose sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
- Variation in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
- Variation in fasting and postprandial glucose(6 weeks)
- Variation in fasting and postprandial insulin(6 weeks)
- Variation in fasting and postprandial plasma C-peptide(6 weeks)
- Variation in gastric emptying(6 weeks)
- Assessment of free living physical activity(6 weeks)
- Assessment of continuous glucose(6 weeks)
- Assessment of psychosocial stress(6 weeks)
- Feasibility of the test and training protocols(6 weeks)
- 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
- 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test(6 weeks)
研究者
Cody Garett Durrer
PhD. Postdoc
Rigshospitalet, Denmark