160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All EthnicityGET FITNCT01755962
Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity
A study testing Glycemic Load and Resistance Training in people with 160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This project is prompted by the urgent public health need to identify novel strategies to prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD, T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- 160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity
- What is being tested?
- Glycemic Load and Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 14 Dec 2017
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 with BMI≥30 and/or your waist circumference ≥40 inches for males or ≥35 inches for females
- In good health as determined by the screening visit and review of medical history
Who cannot join
- Have a known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading or use of medications that influence CV function
- Have been in a weight loss or exercise program in the 6 months prior to participation
- Use tobacco products
- Have a syndrome or are prescribed medications that may influence body composition, insulin action, or CVD (e.g. PCOS, prednisone, methylphenidate, etc.)
- Have intolerance to lactose or gluten
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
This project is prompted by the urgent public health need to identify novel strategies to prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD, T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative.
Read the detailed description
At present, the extent to which dietary components can modify endothelial function, monocyte inflammation and glycemic variations is not well defined, although different carbohydrates are known to vary in their abilities to induce plasma glucose and insulin responses. Epidemiologic work suggests that high dietary glycemic load (GL) is associated with increased concentrations of inflammatory cytokines, endothelial dysfunction markers, and increased risk of T2D and coronary heart disease (CHD). We are examining using randomized control trials low vs. high-GL diet to determine if low-GL diets induce improvements in endothelial function or monocyte inflammation. Furthermore, resistance training is an alternate form of exercise from conventional aerobic training. Resistance Training has the potential to improve endothelial function or monocyte phenotype, but there is very little data in this area. We hypothesize that resistance training may augment the beneficial effects of a low-GL diet in improving metabolic health.
- Conditions
- 160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity
- Being tested
- Glycemic Load, Resistance Training
- Keywords
- diet, obese, overweight, exercise, resistance training, nutrition, glycemic load, body composition, weight training, lifestyle
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic LoadOther
Resistance TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Load + Resistance Training | Experimental | 12-week intervention diet + resistance training (1 hour, 3 times per week) Receives: Other: Glycemic Load; Other: Resistance Training |
| High Glycemic Load + Resistance Training | Experimental | 12-week control diet + resistance training (1 hour, 3 times per week) Receives: Other: Glycemic Load; Other: Resistance Training |
| Low Glycemic Load | Experimental | 12-week intervention diet Receives: Other: Glycemic Load |
| High Glycemic Load | Other | 12-week control diet Receives: Other: Glycemic Load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function as determined by brachial artery FMD
Measured: 12 weeks
Secondary outcomes (3)
monocyte inflammation
Measured: 12 weeks
Insulin Sensitivity by Oral Glucose Tolerance Test
Measured: 12 weeks
MAGE via Continuous Glucose Monitoring System
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 posted24 Dec 2012 (estimated)
- Study startApr 2012
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All EthnicityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Factorial
- Model description
- There are four intervention arms designed to compare two factors, glycemic load and resistance training. Arms consist of high glycemic diet, no exercise, high glycemic diet, resistance training; low glycemic diet, no exercise; low glycemic diet, resistance training.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Carpenter, PhD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755962
- Sponsor's protocol ID
- 546464
- Acronym
- GET FIT
- Status last verified
- Nov 2020
- First submitted
- 11 Oct 2012
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT01755962
- Acronym / sponsor ID
- GET FIT / 546464
- Conditions
- 160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity
- Keywords
- diet, obese, overweight, exercise, resistance training, nutrition, glycemic load, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 24 Dec 2012 (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.
This project is prompted by the urgent public health need to identify novel strategies to prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD, T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative.
Detailed description
At present, the extent to which dietary components can modify endothelial function, monocyte inflammation and glycemic variations is not well defined, although different carbohydrates are known to vary in their abilities to induce plasma glucose and insulin responses. Epidemiologic work suggests that high dietary glycemic load (GL) is associated with increased concentrations of inflammatory cytokines, endothelial dysfunction markers, and increased risk of T2D and coronary heart disease (CHD). We are examining using randomized control trials low vs. high-GL diet to determine if low-GL diets induce improvements in endothelial function or monocyte inflammation. Furthermore, resistance training is an alternate form of exercise from conventional aerobic training. Resistance Training has the potential to improve endothelial function or monocyte phenotype, but there is very little data in this area. We hypothesize that resistance training may augment the beneficial effects of a low-GL diet in improving metabolic health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There are four intervention arms designed to compare two factors, glycemic load and resistance training. Arms consist of high glycemic diet, no exercise, high glycemic diet, resistance training; low glycemic diet, no exercise; low glycemic diet, resistance training.
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Load + Resistance Training | Experimental | Other: Glycemic Load, Other: Resistance Training12-week intervention diet + resistance training (1 hour, 3 times per week) |
| High Glycemic Load + Resistance Training | Experimental | Other: Glycemic Load, Other: Resistance Training12-week control diet + resistance training (1 hour, 3 times per week) |
| Low Glycemic Load | Experimental | Other: Glycemic Load12-week intervention diet |
| High Glycemic Load | Other | Other: Glycemic Load12-week control diet |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-35 with BMI≥30 and/or your waist circumference ≥40 inches for males or ≥35 inches for females
- In good health as determined by the screening visit and review of medical history
Key exclusion criteria (6 listed)
- Have a known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading or use of medications that influence CV function
- Have been in a weight loss or exercise program in the 6 months prior to participation
- Use tobacco products
- Have a syndrome or are prescribed medications that may influence body composition, insulin action, or CVD (e.g. PCOS, prednisone, methylphenidate, etc.)
- Have intolerance to lactose or gluten
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 |
|---|---|---|
| Glycemic Load | Other | High Glycemic Load, High Glycemic Load + Resistance Training, Low Glycemic Load, Low Glycemic Load + Resistance Training |
| Resistance Training | Other | High Glycemic Load + Resistance Training, Low Glycemic Load + Resistance Training |
Primary outcome
Endothelial function as determined by brachial artery FMD
Time frame: 12 weeks
3 secondary outcomes
monocyte inflammation
Time frame: 12 weeks
Insulin Sensitivity by Oral Glucose Tolerance Test
Time frame: 12 weeks
MAGE via Continuous Glucose Monitoring System
Time frame: 12 weeks
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 16 Nov 2020.
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.
Catherine Carpenter, PhD, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycemic Load and Resistance Training in people with 160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity, run by University of California, Los Angeles 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 2 inclusion and 6 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 16 Nov 2020. 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?
Endothelial function as determined by brachial artery FMD (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2020.