DiabetesNCT02043405
Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity
A study testing Weight loss and exercise training intervention and Weight loss Only Intervention in people with Diabetes and Pre-diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Pre-diabetes
- What is being tested?
- Weight loss and exercise training intervention and Weight loss Only Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 3 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity.
The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.
- Conditions
- Diabetes, Pre-diabetes
- Being tested
- Weight loss and exercise training intervention, Weight loss Only Intervention
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss and exercise training interventionBehavioural
Combined weight loss and exercise training intervention
Weight loss Only InterventionBehavioural
Weight loss Only Intervention
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training and Weight Loss Intervention | Experimental | Combination weight loss/exercise training, on insulin sensitivity, muscle lipid composition and localization in skeletal muscle. Receives: 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. Receives: Behavioral: Weight loss Only Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Change in insulin sensitivity measured before and after the 3 month weight loss and exercise training intervention
Measured: baseline and 3 months
Secondary outcomes (1)
Change in membrane localized diacylglycerol species
Change in concentration of membrane and cytosolic diacylglycerol species before and after the intervention. Diacylglycerol is a lipid known to be related to insulin resistance.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion3 Aug 2015
- Study completion3 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Bryan Bergman, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043405
- Sponsor's protocol ID
- 13-1551
- Other IDs
- UL1TR001082
- Status last verified
- Apr 2022
- First submitted
- 16 Jan 2014
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37186949
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity.
- ClinicalTrials.gov ID
- NCT02043405
- Acronym / sponsor ID
- 13-1551
- Conditions
- Diabetes, Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jan 2014
- Primary completion
- 3 Aug 2015 (actual)
- Study completion
- 3 Aug 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training and Weight Loss Intervention | Experimental | Behavioral: Weight loss and exercise training interventionCombination weight loss/exercise training, on insulin sensitivity, muscle lipid composition and localization in skeletal muscle. |
| 4 Month Weight Loss Only Intervention | Active comparator | Behavioral: Weight loss Only InterventionUse exercise training and weight loss as separate interventions in obese subjects with and without pre-diabetes. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Obese men and women with pre-diabetes; (BMI 30-40 kg/m2)
- Ages ranging from 30-60 years old;
- Individuals with:
- 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.
Key exclusion criteria (8 listed)
- Regular exercise more than 2 hours/week,
- medications that could affect glucose,
- lipid metabolism,
- thyroid disease,
- history of lung disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss and exercise training interventionCombined weight loss and exercise training intervention | Behavioural | Exercise Training and Weight Loss Intervention |
| Weight loss Only InterventionWeight loss Only Intervention | Behavioural | 4 Month Weight Loss Only Intervention |
Primary outcome
Change in insulin sensitivity
Time frame: baseline and 3 months
Change in insulin sensitivity measured before and after the 3 month weight loss and exercise training intervention
1 secondary outcome
Change in membrane localized diacylglycerol species
Time frame: baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 37186949Zarini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Bergman, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss and exercise training intervention and Weight loss Only Intervention in people with Diabetes and Pre-diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.