NCT02150889

Brief Summary

The investigators are interested in how skeletal muscle processes fat and how this may affect insulin resistance. This is an important question since insulin resistance predates and predicts type 2 diabetes. The investigators are especially interested in learning about the effects of weight and training on insulin resistance. The investigators will study people before and after supervised aerobic or yoga training to identify differences in resting fat and sugar metabolism which may lead to differences in insulin resistance. The investigators will test these differences using stable isotopes, and the use of these stable isotopes is experimental. Overweight/Obese Group: Eight visits will be required at the University of Minnesota Clinical Research Unit. Four visits will be done before training (screen and 3 pre-training visits), 1 visit during the training, and 3 post-training visits will be done. In between, the training will take about 16 weeks and will be a supervised treadmill program. Lean/Trained Group: Four visits will be required at the University of Minnesota Clinical Research Unit (screen and 3 study visits).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jul 2014

Longer than P75 for not_applicable

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%
Jul 2014Dec 2026

First Submitted

Initial submission to the registry

May 22, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

May 22, 2014

Last Update Submit

January 6, 2026

Conditions

Keywords

insulin resistancelipid metabolismdiabetes

Outcome Measures

Primary Outcomes (1)

  • Differences in insulin sensitivity between groups

    Will use HOMA-IR and hyperinsulinemia-euglycemic clamp

    Before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks)

Secondary Outcomes (1)

  • Differences in fitness level between groups

    before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks)

Other Outcomes (1)

  • Differences in body composition between groups

    before and after exercise program ((exercise program will take 16 weeks, expected average for evaluation will be 20 weeks)

Study Arms (2)

Lean Trained

NO INTERVENTION

Metabolic control

Obese or Overweight

EXPERIMENTAL

Running Program Yoga Program

Behavioral: Running ProgramBehavioral: Yoga Program

Interventions

Running ProgramBEHAVIORAL

16 week supervised running program

Obese or Overweight
Yoga ProgramBEHAVIORAL

once weekly supervised yoga

Obese or Overweight

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects
  • Subjects 18 to 40 years of age.
  • Subjects are capable of giving informed consent
  • Overweight or obese
  • Insulin resistant based on screening oral glucose tolerance testing.
  • BMI 25 to 40 kg/m2 inclusive
  • Stable weight for at least 3 months (± 5 lbs.)
  • Sedentary status (self-report \< 30 minutes/week regular exercise).
  • Lean, physically active
  • physically active subjects defined as 3-5 aerobic exercise sessions/week
  • matched to age and gender
  • generally healthy with normal fasting glucose levels (glucose ≤100 mg/dL).

You may not qualify if:

  • All subjects
  • Subjects 18 to 40 years of age.
  • Subjects are capable of giving informed consent
  • Overweight or obese
  • Insulin resistant based on screening oral glucose tolerance testing.
  • BMI 25 to 40 kg/m2 inclusive
  • Stable weight for at least 3 months (± 5 lbs.)
  • Sedentary status (self-report \< 30 minutes/week regular exercise).
  • Lean, physically active
  • physically active subjects defined as 3-5 aerobic exercise sessions/week
  • matched to age and gender
  • generally healthy with normal fasting glucose levels (glucose ≤100 mg/dL).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

  • Nelson AB, Chow LS, Stagg DB, Gillingham JR, Evans MD, Pan M, Hughey CC, Myers CL, Han X, Crawford PA, Puchalska P. Acute aerobic exercise reveals that FAHFAs distinguish the metabolomes of overweight and normal-weight runners. JCI Insight. 2022 Apr 8;7(7):e158037. doi: 10.1172/jci.insight.158037.

  • Bantle AE, Bosch TA, Dengel DR, Wang Q, Mashek DG, Chow LS. DXA-Determined Regional Adiposity Relates to Insulin Resistance in a Young Adult Population with Overweight andObesity. J Clin Densitom. 2019 Apr-Jun;22(2):287-292. doi: 10.1016/j.jocd.2018.06.001. Epub 2018 Jun 7.

MeSH Terms

Conditions

OverweightObesityInsulin ResistanceDiabetes Mellitus

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Lisa S. Chow, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 30, 2014

Study Start

July 1, 2014

Primary Completion

December 30, 2018

Study Completion (Estimated)

December 31, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations