Recruiting

Exercise and Protein Efficiency in T2D

ClinicalTrials.gov IDNCT07477067

PhaseNA

Enrollment30

SponsorUniversity of Illinois at Urbana-Champaign

Age65 Years

SexALL

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Conditions studied

Type 2 Diabetes, Control Condition

About this study

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.

Interventions

Other: 12 week progressive exercise training — moderate - 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.

Primary outcomes

Define how exercise modifies protein efficiency in T2D (From enrollment to end of 12-week intervention)

Eligibility information

Inclusion Criteria: * 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 T2D group: -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) Exclusion Criteria: * 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. * Untreated hypothyroidism, epilepsy, medications that affect vasoactivity, possibility of pregnancy, and any neurological, cardiovascular, or musculoskeletal disease that precludes exercise testing.

Study locations

Freer Hall - University of Illinois, Urbana, Illinois 61801 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.