Exercise and Protein Efficiency in T2D
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Illinois at Urbana-Champaign
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 65 years old
Body mass index: 25-40 kg/m²
Female: Waist to hip ratio >0.8
Male: Waist to hip ratio >1.0
Disqualifiers
Uncontrolled diabetes (evidence of HbA1c > 10%, prescription of insulin)
Diagnoses of diabetic neuropathy or failing diabetic neuropathy screening
Statins
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.
Trial design
Design model
Parallel
Treatments tested in this trial
12 week progressive exercise training
Other interventionmoderate - to - vigorous aerobic and strength-based exercise training will be performed 2-3 times per week for 12 weeks. Strength Training consists of a 5-minute warm-up on a stationary bike, followed by 1-3 sets on the leg press, leg extension, and leg curl machines. In addition, participants will preform upper body exercises on guided motion machines (seated chest press, shoulder press, seated rows) on alternate training days. Training intensity will gradually increase on each participants comfort level. Endurance training will be performed on a stationary bike. Exercise intensity will be controlled by heart rate and rate of perceived exertion (RPE) using the Borg's original scale (6-20 points). Weeks 1--3 will be at 50-60% of max heart rate for 30 minutes; weeks 4-6 will be at 50-60% of max heart rate for 40 minutes; weeks 7-9 will be 60-70% of max heart rate for 50 minutes; and weeks 10-12 will be at 60-70% of max heart rate for 60 minutes.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Non-DiabeticActive comparator 1 intervention
Group B: Diabetic groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Define how exercise modifies protein efficiency in T2D
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
Time frame
From enrollment to end of 12-week interventionSecondary outcomes
1
Impact of training on gut microbiota on derived metabolites
Exercise training in older adults with T2D shifts aromatic amino acid (ArAA) metabolism toward beneficial aryl-lactates (e.g., PLA) and away from harmful aryl-acetates (e.g., PAG). Pre- and post-exercise intervention conversion of phenylalanine will be assessed with acute labeled 13C6 Phe ingestion. Downstream labeled Phe metabolites (ng/mL) will be quantified in blood serum over 5 hours post-labeled Phe intake.
Time frame
from pretesting to post testing following a 12-week exercise interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Urbana-Champaign
Lead sponsor
American Diabetes Association
Collaborator
Source ClinicalTrials.gov