ObesityNCT06129110
Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling
A study testing Diet Weight Loss in people with Obesity and Insulin Sensitivity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this intervention study is to learn about how weight loss impacts molecular signaling of intermuscular adipose tissue (IMAT) in individuals with obesity. The main question it aims to answer is how inflammatory molecules secreted by IMAT promote muscle insulin resistance and inflammation, and how these same… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Sensitivity, Muscle Weakness
- What is being tested?
- Diet Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 1 Sep 2028
- Phase
- Interventional
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy men and women aged 18-70
- BMI between 30-40
- Less than 1 hour of exercise per week
- Women:
- may be pre or post menopausal
Who cannot join
- Type 1 or Type 2 diabetes
- Thyroid disease
- History of lung disease
- Active use of nicotine
- Severe plasma lipid disorders
- Taking hormone replacement drugs, blood thinners, or thiazoladinediones
Show all 10Show fewer
- Women:
- Currently going through menopause or peri-menopause
- Pregnant or breastfeeding
- History of Polycystic Ovary Syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz
Aurora, Colorado, 80045
Bryan Bergman, PhD
Bryan Bergman, PhD
About this study
The goal of this intervention study is to learn about how weight loss impacts molecular signaling of intermuscular adipose tissue (IMAT) in individuals with obesity. The main question it aims to answer is how inflammatory molecules secreted by IMAT promote muscle insulin resistance and inflammation, and how these same molecules are diminished after weight loss. Following screening visits involving body composition measures, blood testing, strength testing, and a thigh muscle biopsy, participants will go through a 12-week dietary intervention for weight loss. After 12 weeks, this will be followed by the same testing and biopsies that were completed before the intervention. Researchers will then compare outcomes of individuals who lost weight to individuals who did not lose weight.
- Conditions
- Obesity, Insulin Sensitivity, Muscle Weakness, Adiposity, Insulin Resistance
- Being tested
- Diet Weight Loss
- Keywords
- IMAT, Intermuscular Adipose Tissue, Weight Loss, Diet
- Medical subject headings
- Obesity, Insulin Resistance, Muscle Weakness, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet Weight LossBehavioural
Low calorie diet of meal replacement shakes
| Study group | Role | What they receive |
|---|---|---|
| Diet Weight Loss | Experimental | Low calorie meal replacement shakes Receives: Behavioral: Diet Weight Loss |
| Delayed Intervention | No intervention | Normal feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Participants will undergo a standard 3-hour hyperinsulinemic/euglycemic clamp with insulin infused at 80 mU/m2/min, and glucose clamped at 90 mg/dl with a variable dextrose infusion.
Measured: 12 weeks
Body Weight
Participant weight will be measured using BodyTrace scales during the 12 week intervention.
Measured: 12 weeks
IMAT Content
A multi-slice MRI will be used to quantify IMAT and muscle content in both legs with acquisition of ~20 axial images (10 mm thickness) with 10 mm spacing between images starting superior to the patella. IMAT content will be quantified using the well-validated Sirlin 6-echo method and normalized to muscle volume.
Measured: 12 weeks
Muscle Mass
A multi-slice MRI will be used to quantify IMAT and muscle content in both legs with acquisition of ~20 axial images (10 mm thickness) with 10 mm spacing between images starting superior to the patella. Muscle volume will be quantified using standard methods with anatomical cross-sectional area evaluated in each T1 weighted, high resolution, gradient echo profile scan, and multiplied by the length of the muscle.
Measured: 12 weeks
Muscle Strength
Participants will perform quadriceps muscle strength testing using an isokinetic dynamometer.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start31 Jan 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129110
- Sponsor's protocol ID
- 23-0545
- Other IDs
- 1R01DK134706-01A1
- Status last verified
- May 2026
- First submitted
- 8 Nov 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No