NCT02043405

Brief Summary

The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2015

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

January 16, 2014

Last Update Submit

April 21, 2022

Conditions

DiabetesPre-diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in insulin sensitivity

    Change in insulin sensitivity measured before and after the 3 month weight loss and exercise training intervention

    baseline and 3 months

Secondary Outcomes (1)

  • Change in membrane localized diacylglycerol species

    baseline and 3 months

Study Arms (2)

Exercise Training and Weight Loss Intervention

EXPERIMENTAL

Combination weight loss/exercise training, on insulin sensitivity, muscle lipid composition and localization in skeletal muscle.

Behavioral: Weight loss and exercise training intervention

4 Month Weight Loss Only Intervention

ACTIVE COMPARATOR

Use exercise training and weight loss as separate interventions in obese subjects with and without pre-diabetes.

Behavioral: Weight loss Only Intervention

Interventions

Weight loss and exercise training interventionBEHAVIORAL

Combined weight loss and exercise training intervention

Exercise Training and Weight Loss Intervention
Weight loss Only InterventionBEHAVIORAL

Weight loss Only Intervention

4 Month Weight Loss Only Intervention

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obese men and women with pre-diabetes; (BMI 30-40 kg/m2)
  • Ages ranging from 30-60 years old;
  • Individuals with:
  • impaired fasting glucose (IFG), (between 100-125mg/dl, with post-prandial glucose (\<140 mg/dl 2 hrs after 75g OGTT)
  • impaired glucose tolerance (IGT), (normal fasting glucose \<100mg/dl, with post-prandial glucose (\>140 mg/dl 2 hrs after 75g OGTT)
  • a combination of the two (IFG/IGT) (both impaired fasting glucose (100-125mg/dl), and impaired glucose tolerance (\>140 mg/dl 2 hrs after 75g OGTT), will be verified using oral glucose tolerance testing at initial screening, and
  • Sedentary (\<2 hours/week of planned physical activity).
  • To increase generalizability, and because each subject serves as their own control, women will be enrolled regardless of menopausal status, use of hormone replacement therapy and oral contraceptives.

You may not qualify if:

  • Regular exercise more than 2 hours/week,
  • medications that could affect glucose,
  • lipid metabolism,
  • thyroid disease,
  • history of lung disease,
  • pregnancy,
  • active cigarette smoking or exposure to second hand smoke, and
  • Severe plasma lipid disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Zarini S, Zemski Berry KA, Kahn DE, Garfield A, Perreault L, Kerege A, Bergman BC. Deoxysphingolipids: Atypical Skeletal Muscle Lipids Related to Insulin Resistance in Humans That Decrease Insulin Sensitivity In Vitro. Diabetes. 2023 Jul 1;72(7):884-897. doi: 10.2337/db22-1018.

    PMID: 37186949DERIVED

MeSH Terms

Conditions

Diabetes MellitusGlucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Bryan Bergman, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

August 3, 2015

Study Completion

August 3, 2015

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

US(1)