NCT01911104

Brief Summary

The purpose of this study is to collect data to help researchers identify factors that prevent certain individuals from receiving the beneficial effects of exercise.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
6mo left

Started Oct 2013

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2013Dec 2026

First Submitted

Initial submission to the registry

July 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 31, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2016

Completed
10.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

July 23, 2013

Last Update Submit

March 25, 2026

Conditions

Type 2 Diabetes

Keywords

musclemitochondrial functionexercise resistancehumanmyotubesepigenetics

Outcome Measures

Primary Outcomes (1)

  • Change in ATPmax

    The primary endpoint of the study is the maximal capacity for mitochondrial ATP synthesis (ATPmax) measured using 31P magnetic resonance spectroscopy (MRS).

    Baseline and 10 weeks

Secondary Outcomes (1)

  • Change in in vivo and in vitro mitochondrial function

    Baseline and 10 weeks

Other Outcomes (1)

  • Promoter methylation

    Baseline

Study Arms (2)

Exercise

EXPERIMENTAL

10 weeks of aerobic exercise

Behavioral: Exercise

Active Control

NO INTERVENTION

Young athletes as a trained control

Interventions

ExerciseBEHAVIORAL

10 weeks of aerobic exercise

Exercise

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30 to 65 years.
  • Male and Female
  • Type 2 diabetes determined by self-report or by a fasting glucose \> 126mg/dl
  • POCT HbA1c result is 5.7-8.8% or for those on anti-diabetic medications, POCT HbA1c \< 8.9% (no lower limit defined to account for those who illustrate tight glycemic control due to anti-diabetic medications).
  • HbA1c between 6.0% and 8.5% or for those on anti-diabetic medications, HbA1c ≤ 8.5% (no lower limit defined to account for those who illustrate tight glycemic control due to anti-diabetic medications). If a participant misses the screening HbA1c by a small margin (HbA1c ± 0.1%), the HbA1c can be repeated once.
  • Not involved in regular exercise program
  • Willing to exercise every day for the study period
  • If applicable, those currently taking anti-diabetic medication are taking metformin, a sulfonylurea, DPP IV inhibitor, alpha-glucosidase inhibitor, a meglitinide, colesevelam, cycloset or a SGLT2 inhibitor. Those taking 2 of these medications may proceed.
  • If applicable, willing to cease anti-diabetic medication use for the duration of the intervention.
  • BMI ≥ 22 kg/m2
  • Age 18 to 50 years
  • Male and Female
  • Engaged in a minimum of 4 cumulative hours of moderate to vigorous intensity aerobic exercise, over a minimum of 3 days per week.
  • BMI between 18 and 29.9 kg/m2
  • VO2max \> 45 ml/min/kg BW
  • +5 more criteria

You may not qualify if:

  • Resting blood pressure ≥ 160/100 mm Hg (A)
  • Triglycerides \> 500 mg/dL (A)
  • HbA1c ≥ 6.5% (ND)
  • Previous or current use of an insulin pump or multiple insulin injections per day or any diabetes medications that the participant cannot refrain from for the duration of the study. (A)
  • Treatment with thiazolidinediones (TZDs) or GLP-1 agonists within the last 3 months. (A)
  • Unable or unwilling to communicate with staff or to provide written informed consent. (A)
  • Failure to complete baseline testing. (A)
  • Not physically capable of performing the exercise required of the study protocols. (Ex)
  • Consuming \>14 alcoholic beverages per week. (A)
  • Plans to be away \>2 weeks in the next 3 months. (A)
  • Lack of support from primary health care provider and/or family members.(Ex)
  • Significant weight loss in the past year (\>20 lbs) or current use of weight loss medications. (A)
  • Bariatric surgery or planning bariatric surgery in the next 6 months.(Ex)
  • Presence of clinically significant abnormalities on ECG (A)
  • Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the Investigator would compromise participant safety (A)
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (3)

  • Whytock KL, Pino MF, Sun Y, Yu G, De Carvalho FG, Yeo RX, Vega RB, Parmar G, Divoux A, Kapoor N, Yi F, Cornnell H, Patten DA, Harper ME, Gardell SJ, Smith SR, Walsh MJ, Sparks LM. Comprehensive interrogation of human skeletal muscle reveals a dissociation between insulin resistance and mitochondrial capacity. Am J Physiol Endocrinol Metab. 2023 Oct 1;325(4):E291-E302. doi: 10.1152/ajpendo.00143.2023. Epub 2023 Aug 16.

    PMID: 37584609DERIVED

  • Carnero EA, Bock CP, Distefano G, Corbin KD, Stephens NA, Pratley RE, Smith SR, Goodpaster BH, Sparks LM. Twenty-four hour assessments of substrate oxidation reveal differences in metabolic flexibility in type 2 diabetes that are improved with aerobic training. Diabetologia. 2021 Oct;64(10):2322-2333. doi: 10.1007/s00125-021-05535-y. Epub 2021 Aug 17.

    PMID: 34402932DERIVED

  • Pino MF, Stephens NA, Eroshkin AM, Yi F, Hodges A, Cornnell HH, Pratley RE, Smith SR, Wang M, Han X, Coen PM, Goodpaster BH, Sparks LM. Endurance training remodels skeletal muscle phospholipid composition and increases intrinsic mitochondrial respiration in men with Type 2 diabetes. Physiol Genomics. 2019 Nov 1;51(11):586-595. doi: 10.1152/physiolgenomics.00014.2019. Epub 2019 Oct 7.

    PMID: 31588872DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lauren M Sparks, PhD

    Translational Research Institute for Metabolism and Diabetes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 30, 2013

Study Start

October 31, 2013

Primary Completion

June 15, 2016

Study Completion (Estimated)

December 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

US(1)