ObesityNCT01040663
Isocaloric Dietary Interventions for Insulin Resistance and the Metabolic Syndrome
A study testing Dietary intervention in people with Obesity, run by Rockefeller University at 1 site in United States.
Trial summary
In recent decades, the prevalence of obesity has increased dramatically in the United States. Obesity has been associated with an increased risk of the metabolic syndrome, which is characterized by a cluster of metabolic derangements, including insulin resistance, high blood sugar, high triglycerides, low high density… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonsmoking men and postmenopausal women, ages 18 - 65. Premenopausal women who would not be expected to have significant fluctuations in estrogen and progesterone levels during the study (e.g. those on continuous monophasic hormonal contraception) may be included in the study at the discretion of the PI or designated study staff.
- Body mass index (BMI) of at least 27 kg/m2
- Body weight < 200 kg (the weight limit of the Bod Pod® scale)
- Evidence of insulin resistance, as suggested by any one of the following:
- Fasting glucose of 100 mg/dL or higher
- Impaired glucose tolerance, with a glucose concentration of 140 mg/dL or higher, 2 hours after a 75-gram oral glucose challenge.
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- A fasting insulin concentration of 9 mIU/L or higher
- Willingness to consume only study food and drink for the duration of the study
- Willingness to be randomized to any one of the three study diets
- If applicable, willingness to maintain consistent intake of coffee and/or tea during the inpatient periods (due to the potential effects of these drinks on inflammatory markers)
- Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study. At the PI's discretion, other nutritional supplements, such as iron, may also be continued during the study if they are deemed medically necessary and are unlikely to influence study results.
- If applicable, willingness to continue current antihypertensive medications (especially angiotensin converting enzyme inhibitors and angiotensin receptor blockers, which may affect levels of inflammatory markers) at the same dose and schedule throughout the study,unless a change is advised by the subject's primary care provider or the study investigators
- Willingness to avoid the use of non-steroidal anti-inflammatory drugs (NSAIDS), including low-dose daily aspirin, throughout the inpatient admission, (due to the potential effects of these agents on inflammatory markers).
- at least two of the following:
- waist circumference greater than 35" in women or 40" in men
- blood pressure greater than 120/80 mmHg but less than 150/90 mmHg (on 2 blood pressure medications or less)
- triglyceride level greater than 150 but less than 500 mg/dL
- HDL ("good") cholesterol less than 40 mg/dL in men or 50 mg/dL in women
Who cannot join
- Current tobacco smoking
- History of a bleeding disorder
- Known or suspected cardiovascular disease, including angina, myocardial infarction, medical or surgical treatment for atherosclerotic disease, arrhythmia, or congestive heart failure
- Blood pressure higher than 145/90 after 10 minutes of rest, confirmed on two or more visits, or treatment with three or more antihypertensive agents at any blood pressure. Subjects taking up to two antihypertensive agents may be included in the study if 1) BP is at least 115/75 mmHg but < 145/90 mmHg on these agents and 2) they agree to remain on the same medications (and same dosages) during the study, unless otherwise advised by a primary care provider or study investigators (e.g. the dosage may be reduced or the medication may be stopped if signs or symptoms of hypotension develop during the study)
- Fasting glucose > 165 mg/dL, glycosylated hemoglobin > 8%, or any treatment with oral hypoglycemic agents, insulin sensitizing agents (e.g. metformin or thiazolidinediones), insulin, incretin mimetics (e.g. exenatide), amylin analogues (e.g. pramlintide), or endocannabinoid receptor antagonists (e.g. rimonabant). Volunteers with type 2 diabetes and a glycosylated hemoglobin level of 7.5% or higher will be encouraged to discuss treatment options (e.g. pharmacotherapy versus study participation) with their primary care providers before enrolling in the study
- History of chronic glucocorticoid use, oral glucocorticoid use for more than 5 days in the previous year, or anticipated treatment with oral or intravenous glucocorticoids during the study period. Daily, low-dose, inhaled or nasal glucocorticoids may be acceptable in some cases, at the discretion of the Principal Investigator.
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- Current treatment with over-the-counter or prescription weight loss medications, such as orlistat or sibutramine
- History of bariatric surgery
- Current treatment with any cholesterol-lowering medications, such as statins, niacin,fibrates, or ezetimibe
- Hyperthyroidism or untreated hypothyroidism. Subjects with chronic, treated, stable hypothyroidism may be included in the study at the discretion of the Principal Investigator
- Obstructive sleep apnea, or significant symptoms suggestive of this condition
- Active gallstone disease
- Known history of chronic hepatitis, or liver enzymes (AST or ALT) more than 2.5 times the upper limit of normal
- Known infection with HIV or confirmed positive test for HIV antibody
- Inflammatory bowel disease, active cancer, or any other medical condition that may cause significant acute weight loss or gain
- Sustained weight loss > 5% of body weight in the previous two months, or sustained weight loss > 10% of body weight in the previous six months
- History of kidney stones
- Chronic or acute renal disease
- Serum calcium, potassium, or magnesium above the normal limit, confirmed on two screening tests
- Seizure disorder
- History of any inpatient psychiatric admission within the past two years
- History of schizophrenia, psychosis, or bipolar disorder
- History of anorexia nervosa or bulimia nervosa, as defined in the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), or a history of medical or psychological treatment for an eating disorder
- Severe binge eating disorder, as defined as a Binge Eating Scale score of 27 or more. Individuals with scores of 18-26, which may be indicative of moderate eating disturbances, will be evaluated further to determine whether moderate to severe eating pathology actually exists. This evaluation process will be based on the DSMIVresearch criteria for binge eating disorder. Individuals with scores of 18-26 who meet the DSM-IV research criteria for binge eating disorder will be excluded, whereas those without significant eating pathology may be included in the study.
- Untreated moderate to severe depression, as evidenced by a Beck Depression Inventory score of 20 or higher at screening. Subjects with a remote history of depression or stable, treated depression may be included in the study at the discretion of the Principal Investigator
- History of alcohol or drug abuse within the previous two years
- History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study.
- Any social or behavioral condition that, in the opinion of the investigator, would interfere with adherence to study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
In recent decades, the prevalence of obesity has increased dramatically in the United States. Obesity has been associated with an increased risk of the metabolic syndrome, which is characterized by a cluster of metabolic derangements, including insulin resistance, high blood sugar, high triglycerides, low high density lipoprotein (HDL) cholesterol levels, high blood pressure, and inflammation. Lifestyle interventions, including dietary modification, physical activity, and weight loss, form the basis of treatment for individuals with the metabolic syndrome. However, the optimal composition of the diet is not known at this time. Furthermore, due to hormonal and metabolic changes that accompany weight loss, most people find it very difficult to maintain significant weight reductions over time. As a result, weight regain is exceedingly common.
Read the detailed description
Several dietary patterns, including the Dietary Approaches to Stop Hypertension study diet (the DASH diet) and the low glycemic index diet (low GI diet), may be useful in the treatment of individuals with the metabolic syndrome, even if body weight stays the same. Novel findings from our own pilot study suggest that these dietary patterns may improve insulin resistance and some other features of the metabolic syndrome, even after just two weeks and in the absence of weight loss. In this important follow-up study, the metabolic effects of the DASH diet and the low GI diet will be compared to those of an Western-style control diet. At least 39 overweight, insulin-resistant volunteers with the metabolic syndrome will be studied during a 32-day inpatient admission. All food will be provided, and body weight will be kept stable throughout the study. Subjects will first undergo testing after consuming a Western-style diet for two weeks. They will then be randomized to one of three study diets: the DASH diet, the low GI diet, or the Western-style diet. Testing will again be conducted after 2 weeks of weight stability on the study diet. Testing will include the assessment of insulin sensitivity and other metabolic parameters, such as blood sugar and cholesterol levels, blood pressure, and inflammation. This study will provide important information about the effects of these promising dietary patterns on features of the metabolic syndrome, in the absence of weight loss.
- Conditions
- Obesity
- Being tested
- Dietary intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Subjects will be randomly assigned to receive 1 of 3 diets for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dash Diet | Other | Subjects receive DASH diet for 4 weeks Receives: Other: Dietary intervention |
| Low GI Diet | Other | Subjects will receive Low GI diet for 4 weeks Receives: Other: Dietary intervention |
| Western Style Diet | Other | Subjects will receive western style diet for 4 weeks Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic insulin sensitivity from the first testing battery (on Western diet) to the second testing battery (on study diet). Hepatic insulin sensitivity will be assessed using the homeostatic model assessment plasma
Measured: 3 years
Secondary outcomes (1)
Peripheral (muscle) insulin sensitivity, Glycemic control,Glycemic responses to a representative breakfast, Systemic inflammation, blood endotoxin levels, lipids, Systolic and diastolic blood pressure, body composition, and dietary satisfaction.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2013
- Study completionJan 2013
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Neff, MD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040663
- Sponsor's protocol ID
- LNE-0673
- Status last verified
- Apr 2013
- First submitted
- 24 Dec 2009
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isocaloric Dietary Interventions for Insulin Resistance and the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01040663
- Acronym / sponsor ID
- LNE-0673
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Dec 2009 (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.
In recent decades, the prevalence of obesity has increased dramatically in the United States. Obesity has been associated with an increased risk of the metabolic syndrome, which is characterized by a cluster of metabolic derangements, including insulin resistance, high blood sugar, high triglycerides, low high density lipoprotein (HDL) cholesterol levels, high blood pressure, and inflammation. Lifestyle interventions, including dietary modification, physical activity, and weight loss, form the basis of treatment for individuals with the metabolic syndrome. However, the optimal composition of the diet is not known at this time. Furthermore, due to hormonal and metabolic changes that accompany weight loss, most people find it very difficult to maintain significant weight reductions over time. As a result, weight regain is exceedingly common.
Detailed description
Several dietary patterns, including the Dietary Approaches to Stop Hypertension study diet (the DASH diet) and the low glycemic index diet (low GI diet), may be useful in the treatment of individuals with the metabolic syndrome, even if body weight stays the same. Novel findings from our own pilot study suggest that these dietary patterns may improve insulin resistance and some other features of the metabolic syndrome, even after just two weeks and in the absence of weight loss. In this important follow-up study, the metabolic effects of the DASH diet and the low GI diet will be compared to those of an Western-style control diet. At least 39 overweight, insulin-resistant volunteers with the metabolic syndrome will be studied during a 32-day inpatient admission. All food will be provided, and body weight will be kept stable throughout the study. Subjects will first undergo testing after consuming a Western-style diet for two weeks. They will then be randomized to one of three study diets: the DASH diet, the low GI diet, or the Western-style diet. Testing will again be conducted after 2 weeks of weight stability on the study diet. Testing will include the assessment of insulin sensitivity and other metabolic parameters, such as blood sugar and cholesterol levels, blood pressure, and inflammation. This study will provide important information about the effects of these promising dietary patterns on features of the metabolic syndrome, in the absence of weight loss.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dash Diet | Other | Other: Dietary interventionSubjects receive DASH diet for 4 weeks |
| Low GI Diet | Other | Other: Dietary interventionSubjects will receive Low GI diet for 4 weeks |
| Western Style Diet | Other | Other: Dietary interventionSubjects will receive western style diet for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Nonsmoking men and postmenopausal women, ages 18 - 65. Premenopausal women who would not be expected to have significant fluctuations in estrogen and progesterone levels during the study (e.g. those on continuous monophasic hormonal contraception) may be included in the study at the discretion of the PI or designated study staff.
- Body mass index (BMI) of at least 27 kg/m2
- Body weight < 200 kg (the weight limit of the Bod Pod® scale)
- Evidence of insulin resistance, as suggested by any one of the following:
- Willingness to consume only study food and drink for the duration of the study
Key exclusion criteria (28 listed)
- Current tobacco smoking
- History of a bleeding disorder
- Known or suspected cardiovascular disease, including angina, myocardial infarction, medical or surgical treatment for atherosclerotic disease, arrhythmia, or congestive heart failure
- Blood pressure higher than 145/90 after 10 minutes of rest, confirmed on two or more visits, or treatment with three or more antihypertensive agents at any blood pressure. Subjects taking up to two antihypertensive agents may be included in the study if 1) BP is at least 115/75 mmHg but < 145/90 mmHg on these agents and 2) they agree to remain on the same medications (and same dosages) during the study, unless otherwise advised by a primary care provider or study investigators (e.g. the dosage may be reduced or the medication may be stopped if signs or symptoms of hypotension develop during the study)
- Fasting glucose > 165 mg/dL, glycosylated hemoglobin > 8%, or any treatment with oral hypoglycemic agents, insulin sensitizing agents (e.g. metformin or thiazolidinediones), insulin, incretin mimetics (e.g. exenatide), amylin analogues (e.g. pramlintide), or endocannabinoid receptor antagonists (e.g. rimonabant). Volunteers with type 2 diabetes and a glycosylated hemoglobin level of 7.5% or higher will be encouraged to discuss treatment options (e.g. pharmacotherapy versus study participation) with their primary care providers before enrolling in the study
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 |
|---|---|---|
| Dietary interventionSubjects will be randomly assigned to receive 1 of 3 diets for 4 weeks. | Other | Dash Diet, Low GI Diet, Western Style Diet |
Primary outcome
Change in hepatic insulin sensitivity from the first testing battery (on Western diet) to the second testing battery (on study diet). Hepatic insulin sensitivity will be assessed using the homeostatic model assessment plasma
Time frame: 3 years
1 secondary outcome
Peripheral (muscle) insulin sensitivity, Glycemic control,Glycemic responses to a representative breakfast, Systemic inflammation, blood endotoxin levels, lipids, Systolic and diastolic blood pressure, body composition, and dietary satisfaction.
Time frame: 3 years
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 10 Apr 2013.
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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.
Lisa Neff, MD principal investigator
The Rockefeller 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 Dietary intervention in people with Obesity, run by Rockefeller 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 18 inclusion and 28 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 10 Apr 2013. 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 hepatic insulin sensitivity from the first testing battery (on Western diet) to the second testing battery (on study diet). Hepatic insulin sensitivity will be assessed using the homeostatic model assessment plasma (time frame: 3 years). 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 10 Apr 2013.