跳至主要内容
临床试验/NCT07477067
NCT07477067招募中不适用

Exercise Impact on Dietary Protein Efficiency in Older Adults With Type 2 Diabetes

University of Illinois at Urbana-Champaign1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Define how exercise modifies protein efficiency in T2D

研究概览

简要总结

In this randomized controlled trial, 30 older adults (aged> 65 years; 15 with T2D, 15 controls) will participate in a 12-week progressive exercise training program. They will undergo pre- and post-testing that includes body composition measures; oral glucose tolerance testing; cardiovascular fitness and muscle performance testing; dietary protein efficiency assessed using the indicator amino acid oxidation (IAAO) method; and a gut microbiota trial. The dietary protein efficiency trial will include repeated ingestion of crystallized amino acids (drink) containing stable isotopes, urine samples, and breath samples. The gut microbiome trial will consist of a single ingestion of a Mediterranean-based modeled meal enriched with 13C-phenylalanine (in the drink) and repeated blood draws. Participants will also be asked to give a fecal sample after the gut microbiome trial.

详细描述

  1. Enrollment, Informed Consent, and Screening Questionnaires: Prior to study enrollment, participants will be asked to read a digital copy of an informed consent document provided using the e-Consent framework through the Research Electronic Data Capture (REDCap) system. Should participants have any questions about the study after reading the document, they will be encouraged to contact the research team prior to providing informed consent. Upon providing informed consent, participants will receive an email containing questionnaires designed to assess study eligibility via REDCap. Specifically, participants will be asked to complete a health and medical history questionnaire, physical activity readiness questionnaire (PARQ), International Physical Activity Questionnaire Long Form (IPAQ), and Godin-Shephard Leisure-Time Physical Activity Questionnaire (LTPAQ). Information from the questionnaires will be used to assess exclusion criteria, and the IPAQ will be used to assess baseline habitual activity level. Upon completion of these questionnaires, the research team will review the responses and determine eligibility.
  2. Preliminary Testing Day 1:

2.1 Preparation: Participants will arrive for the preliminary testing session after an overnight fast (~10 h no caloric foods/beverages consumed) and having refrained from exercise for the 72 h prior.

3.2 Cardiorespiratory fitness assessment: Peak aerobic capacity and maximum heart rate (HR) will be estimated using a submaximal graded stationary bicycle exercise test. Briefly, participants will pedal for 3 minutes at a resistance of 0kg, maintaining a cadence of 50 as a warm-up. Then, the investigators will have the participant pedal for 3-4 minutes, or until a steady state is reached, at 0.5kg, maintaining the same cadence. Resistance is increased every 3-4 minutes until the participant reaches 85% of age-predicted maximal heart rate (220-age).

3.3 Muscle Performance (1RM and power Testing): maximum strength will be assessed using a 10-repetition max (10-RM) on a leg extension, leg press, leg curl, chest press, shoulder press, seated pulldown, and seated row machines. Following a 5-minute warm-up on a stationary bike at a self-selected resistance and speed, participants will perform a set of 8-10 reps at around 50% of what they think they can lift 10 times. 1-2 minutes of rest will be given between each try. The next set will be around 90% of what the participant believes they can lift ten times. investigators will gradually increase the weight by 2.5-5.0% at a time until the participant can no longer lift it. A two-minute rest will be provided between the maximum number of attempts and between exercises.

3.3.5 The HUMAC NORM Isokinetic Dynamometer (CSMi, Stoughton, Massachusetts) will be used to assess peak torque, average workload, and average power in concentric tests and maximal voluntary contraction (MVC). Each participant will be seated upright, with the knee bent. The shank of the dominant leg will be secured to a padded, rigid metal bar using a Velcro strap. With standardized verbal encouragement, participants will perform brief maximal voluntary isometric contractions (MVC), separated by at least 60 seconds of rest, to determine maximal knee extension torque. Maximal power of the knee extensor muscles will be obtained at several test velocities using 2 sets of 4 maximal isokinetic knee extensions, including at a velocity of 60 deg/s. Strong verbal encouragement will be provided to kick as hard and as fast as possible throughout the full range of motion for each velocity. Participants will rest for at least 60 seconds after each set of 4 contractions to minimize muscle fatigue during the power assessment.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 65 years old
  • Body mass index: 25-40 kg/m^2
  • Female: Waist to hip ratio >0.8
  • Male: Waist to hip ratio >1.0
  • Free from structured exercise during the prior 6 months (mo) weight stable for the prior 6 months
  • Diagnosed by a physician with elevated glycosylated hemoglobin (HbA1c) >6.5%
  • Control group:
  • Normoglycemic with HbA1c levels not exceeding 5.6% and fasting blood glucose levels below or equal to 99 mg/dL (5.5mmol)

排除标准

  • Uncontrolled diabetes (evidence of HbA1c > 10%, prescription of insulin)
  • Diagnoses of diabetic neuropathy or failing diabetic neuropathy screening
  • Peripheral edema Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation.
  • Untreated hypothyroidism, epilepsy, medications that affect vasoactivity, possibility of pregnancy, and any neurological, cardiovascular, or musculoskeletal disease that precludes exercise testing.

研究组 & 干预措施

Non-Diabetic

Active Comparator

Non-diabetic control group. Will be assigned to all pre-/post-testing and complete the 12-week intervention period.

干预措施: 12 week progressive exercise training (Other)

Diabetic group

Experimental

Diagnosed diabetic group. Will complete all pre- and post-testing and the 12-week intervention period.

干预措施: 12 week progressive exercise training (Other)

结局指标

主要结局

Define how exercise modifies protein efficiency in T2D

时间窗: From enrollment to end of 12-week intervention

Define how exercise modifies protein efficiency by assessing whole-body net protein balance via amino acid oxidation rates in response to protein intake of 1.0 g protein/kg/d. We expect to observe elevated baseline (pre-training) rates of oxidative excretion in aging T2D compared with CON. Following 12 weeks of exercise, both groups will improve their whole-body net protein balance, (indicative of lower oxidation rates), but the largest effects will be observed in the T2D vs CON group

次要结局

  • Impact of training on gut microbiota on derived metabolites(from pretesting to post testing following a 12-week exercise intervention)

研究者

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

Nicholas Burd

Professor

University of Illinois at Urbana-Champaign

研究点 (1)

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