Exercise and Protein Efficiency in T2D

NCT07477067 | Recruiting

• 2 other identifiers: IRB25-08517-25-ICTSAD-418
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Control Condition

Keywords

Type 2 Diabetes; Obesity; Exercise Intervention; Protein Metabolism

Outcome Measures

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

  From enrollment to end of 12-week intervention

Secondary Outcomes (1)

• Impact of training on gut microbiota on derived metabolites

  from pretesting to post testing following a 12-week exercise intervention

Study Arms (2)

Non-Diabetic

ACTIVE COMPARATOR

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

Other: 12 week progressive exercise training

Diabetic group

EXPERIMENTAL

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

Other: 12 week progressive exercise training

Interventions

12 week progressive exercise training OTHER

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.

Also known as: 12-week progressive training

Diabetic group; Non-Diabetic

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• American Diabetes Association: collaborator

Study Sites (1)

Freer Hall - University of Illinois

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicholas Burd (Professor), PhD

CONTACT

2172440970; naburd@illinois.edu

Gena Irwin (Research Assistant), M.S

CONTACT

3608883281; genai2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: non-Randomized Control Design

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: March 17, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)