ObesityNCT02505958
How Quickly Can the Effects of Excessive Caloric Intake on Insulin Resistance be Reversed?
A study testing high caloric intake and reduced caloric intake in people with Obesity, run by Temple University at 1 site in United States.
Trial summary
Objective: To show that a 1-2 day reduction of caloric intake can reduce the insulin resistance produced by several days of overnutrition. Approach: Healthy volunteers will be admitted to the Clinical Research Center and undergo a baseline euglycemic-hyperinsulinemic clamp study to assess their insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- high caloric intake and reduced caloric intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 31 Dec 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: Subjects with diabetes or a history of obesity surgery or with more than modest health problems
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Objective: To show that a 1-2 day reduction of caloric intake can reduce the insulin resistance produced by several days of overnutrition. Approach: Healthy volunteers will be admitted to the Clinical Research Center and undergo a baseline euglycemic-hyperinsulinemic clamp study to assess their insulin resistance. Subjects will then start on an overnutrition program for 4 days consisting of 3 meals and 3 snacks containing ~6,000 Kcal/24hours. A second clamp study will be performed on day 5 to demonstrate the overnutrition induced increase in insulin resistance. Starting on day 5 the subject's caloric intake will be reduced to ~1,000 Kcal for 2 days (day 5 and 6). After that on the morning of day 7, a third hyperinsulinemic-euglycemic clamp will be performed to determine whether the reduced caloric intake did reduce insulin resistance and the volunteer will be discharged from the Clinical Research Center.
Read the detailed description
Study volunteers will be admitted to the Clinical Research Center at Temple University Hospital. After an overnight fast, body composition will be determined non-invasively by bioimpedance analysis (4) and a 4 h euglycemic-hyperinsulinemic clamp (using only FDA-approved regular insulin) as previously described (5) will be performed during which serum samples will be obtained for measurement of glucose, insulin, free fatty acids, ketone bodies and lipids. Oxidative stress ( 6) will be measured by 24 hour urine collections (analyzed for isoprostane content via 8-isoprostaglandin-F2alpha throughout the study period. Respiratory gas exchange rates (7) will be determined at hourly intervals (with a metabolic cart (True One, Parvo Utah) during the clamp studies and once a day on Days 2 through 6. After that, (at about 1:00 in the afternoon on Day 1) the volunteers will be started on a diet program for 4 ½ days, consisting of 3 meals and 3 snacks over a 24 hour period and containing ~ 6000 Kcal/24 h. The main meals (containing ~ 1500 Kcal/meal) will be served at ~ 8:00 in the morning (breakfast), 1:00 in the afternoon (lunch) and approximately 7:00 in the evening (dinner), the snacks (~ 500 Kcal/each) at approximately 11:00 in the morning, 4:00 in the afternoon and 11:00 in the night. On days 5 and 6, volunteers will receive 3 meals, each will contain ~333 calories. Each morning blood samples will be obtained to measure glucose insulin, free fatty acids and ketone bodies. Daily 24 h urine collections will be obtained each day. In the morning of Days 5 and 7, all procedures described for Day 1 will be repeated. In the afternoon of Day 7, the volunteers will be discharged from the hospital.
- Conditions
- Obesity
- Being tested
- high caloric intake, reduced caloric intake
- Keywords
- insulin resistance, obesity, caloric intake
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high caloric intakeOther
Volunteers will be started on a diet program for 4 ½ days, consisting of 3 meals and 3 snacks over a 24 hour period and containing ~ 6000 Kcal/24 h.
reduced caloric intakeOther
On days 5 and 6, volunteers will received 3 meals (~333 calories each) totaling ~ 1,000 calories/24 hours.
| Study group | Role | What they receive |
|---|---|---|
| high caloric intake | Other | Volunteers will receive 3 meals and 3 snacks over a 24 hour period which will contain ~ 6,000 calories. Main meals will consist of ~ 1,500 calories and snacks will contain ~ 500 calories. Receives: Other: high caloric intake |
| reduced caloric intake | Other | On days 5 and 6 subjects will receive 3 meals only and each meal will contain ~ 333 calories for a total of 1,000/ 24 hours. Receives: Other: reduced caloric intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin resistance
Insulin resistance will be determined by measuring changes in insulin-stimulated total body glucose uptake during euglycemic hyperinsulinemic clamping
Measured: baseline, day 4 and day 7
Changes in oxidative stress
24 hour urine collections analyzed for isoprostane content
Measured: baseline, day1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in energy expenditure
Changes in energy expenditure will be assessed with a metabolic cart (indirect calorimetry)
Measured: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in weight
Subjects will be weighed daily
Measured: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in body composition
Body composition will be determined by bioelectric impedance analysis
Measured: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Secondary outcomes (5)
Changes in blood glucose levels
Daily blood samples will be analyzed to determine glucose levels of glucose.
Measured: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in blood levels of insulin
Daily blood samples will be analyzed to determine insulin levels
Measured: Baseline, day1 day2, day 3, day 4, day 5, day 6, day 7
Changes in blood levels of free fatty acids
Daily blood samples will be analyzed to determine free fatty acid levels
Measured: Baseline, day1 , day 2, day 3, day 4, day 5, day 6, day 7
Changes in blood ketone levels
Daily blood samples will be analyzed to determine ketone levels
Measured: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in glucagon levels
Daily blood samples will be analyzed to determine glucagon levels
Measured: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startAug 2014
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajaykumar Rao, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505958
- Sponsor's protocol ID
- 22331
- Other IDs
- R01DK090588
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2015
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Quickly Can the Effects of Excessive Caloric Intake on Insulin Resistance be Reversed?
- ClinicalTrials.gov ID
- NCT02505958
- Acronym / sponsor ID
- 22331
- Conditions
- Obesity
- Keywords
- insulin resistance, obesity, caloric intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2014
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Jul 2015 (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.
Objective: To show that a 1-2 day reduction of caloric intake can reduce the insulin resistance produced by several days of overnutrition. Approach: Healthy volunteers will be admitted to the Clinical Research Center and undergo a baseline euglycemic-hyperinsulinemic clamp study to assess their insulin resistance. Subjects will then start on an overnutrition program for 4 days consisting of 3 meals and 3 snacks containing ~6,000 Kcal/24hours. A second clamp study will be performed on day 5 to demonstrate the overnutrition induced increase in insulin resistance. Starting on day 5 the subject's caloric intake will be reduced to ~1,000 Kcal for 2 days (day 5 and 6). After that on the morning of day 7, a third hyperinsulinemic-euglycemic clamp will be performed to determine whether the reduced caloric intake did reduce insulin resistance and the volunteer will be discharged from the Clinical Research Center.
Detailed description
Study volunteers will be admitted to the Clinical Research Center at Temple University Hospital. After an overnight fast, body composition will be determined non-invasively by bioimpedance analysis (4) and a 4 h euglycemic-hyperinsulinemic clamp (using only FDA-approved regular insulin) as previously described (5) will be performed during which serum samples will be obtained for measurement of glucose, insulin, free fatty acids, ketone bodies and lipids. Oxidative stress ( 6) will be measured by 24 hour urine collections (analyzed for isoprostane content via 8-isoprostaglandin-F2alpha throughout the study period. Respiratory gas exchange rates (7) will be determined at hourly intervals (with a metabolic cart (True One, Parvo Utah) during the clamp studies and once a day on Days 2 through 6. After that, (at about 1:00 in the afternoon on Day 1) the volunteers will be started on a diet program for 4 ½ days, consisting of 3 meals and 3 snacks over a 24 hour period and containing ~ 6000 Kcal/24 h. The main meals (containing ~ 1500 Kcal/meal) will be served at ~ 8:00 in the morning (breakfast), 1:00 in the afternoon (lunch) and approximately 7:00 in the evening (dinner), the snacks (~ 500 Kcal/each) at approximately 11:00 in the morning, 4:00 in the afternoon and 11:00 in the night. On days 5 and 6, volunteers will receive 3 meals, each will contain ~333 calories. Each morning blood samples will be obtained to measure glucose insulin, free fatty acids and ketone bodies. Daily 24 h urine collections will be obtained each day. In the morning of Days 5 and 7, all procedures described for Day 1 will be repeated. In the afternoon of Day 7, the volunteers will be discharged from the hospital.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high caloric intake | Other | Other: high caloric intakeVolunteers will receive 3 meals and 3 snacks over a 24 hour period which will contain ~ 6,000 calories. Main meals will consist of ~ 1,500 calories and snacks will contain ~ 500 calories. |
| reduced caloric intake | Other | Other: reduced caloric intakeOn days 5 and 6 subjects will receive 3 meals only and each meal will contain ~ 333 calories for a total of 1,000/ 24 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: Subjects with diabetes or a history of obesity surgery or with more than modest health problems
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| high caloric intakeVolunteers will be started on a diet program for 4 ½ days, consisting of 3 meals and 3 snacks over a 24 hour period and containing ~ 6000 Kcal/24 h. | Other | high caloric intake |
| reduced caloric intakeOn days 5 and 6, volunteers will received 3 meals (~333 calories each) totaling ~ 1,000 calories/24 hours. | Other | reduced caloric intake |
Primary outcome
Changes in insulin resistance
Time frame: baseline, day 4 and day 7
Insulin resistance will be determined by measuring changes in insulin-stimulated total body glucose uptake during euglycemic hyperinsulinemic clamping
Changes in oxidative stress
Time frame: baseline, day1, day 2, day 3, day 4, day 5, day 6, day 7
24 hour urine collections analyzed for isoprostane content
Changes in energy expenditure
Time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in energy expenditure will be assessed with a metabolic cart (indirect calorimetry)
Changes in weight
Time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Subjects will be weighed daily
Changes in body composition
Time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Body composition will be determined by bioelectric impedance analysis
5 secondary outcomes
Changes in blood glucose levels
Time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in blood levels of insulin
Time frame: Baseline, day1 day2, day 3, day 4, day 5, day 6, day 7
Changes in blood levels of free fatty acids
Time frame: Baseline, day1 , day 2, day 3, day 4, day 5, day 6, day 7
Changes in blood ketone levels
Time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Changes in glucagon levels
Time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Ajaykumar Rao, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high caloric intake and reduced caloric intake in people with Obesity, run by Temple University 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 0 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: status not confirmed, as of the sponsor's last update on 28 Jul 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?
Results are not available in the source record.
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?
Changes in insulin resistance (time frame: baseline, day 4 and day 7). The study lists 5 primary outcomes in all. 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 28 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.