Metabolic Syndrome XNCT00422630
The Metabolic Effects of Different Weight Loss Diets
A study testing The DASH diet, The low glycemic Index Diet and Reduced calorie American Diet in people with Metabolic Syndrome X and Obesity, run by Rockefeller University at 1 site in United States.
Trial summary
Current estimates suggest that 65% of American adults are overweight or obese. Excess body weight has been associated with an increased risk of a number of metabolic abnormalities, including high blood sugar, high blood pressure, high triglyceride levels, and low HDL ("good") cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Obesity, Insulin Resistance
- What is being tested?
- The DASH diet, The low glycemic Index Diet and Reduced calorie American Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Feb 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonsmoking men and premenopausal women, ages 18-45
- Body mass index ≥ 27 kg/m2
- Body weight < 200 kg
- Evidence of insulin resistance, as suggested by any one of the following:
- Fasting glucose ≥ 100 mg/dL
- Impaired glucose tolerance, with a glucose concentration of ≥ 140 mg/dL 2 hours after a 75-gram oral glucose challenge
Show all 19Show fewer
- A fasting insulin concentration ≥ 9 mIU/L
- At least two of the following:
- Waist circumference > 35" in women or > 40" in men
- Prehypertension or hypertension, with BP > 120/80 mmHg but < 145/90 mmHg on 2 antihypertensive agents or less
- TG > 150 but < 500 mg/dL
- HDL < 40 mg/dL in men or < 50 mg/dL in women
- Willingness to consume only study food and drink for the duration of the study and to be randomized to one of the three diets
- Willingness to maintain consistent intake of coffee and/or tea during the inpatient periods
- Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study, with the exception of the multivitamin supplement (Flintstones® Plus Iron.)
- Willingness to continue current antihypertensive medications at the same dose and schedule throughout the study, unless a change is advised.
- Willingness to avoid the use of non-steroidal anti-inflammatory drugs including low-dose daily aspirin, for at least ten days prior to the first admission and during each admission.
- Willingness to avoid the use of acetaminophen (Tylenol) and furosemide (Lasix) for at least 48 hours prior to and during the 24-hour urine collection.
- Willingness to avoid the use of sulfonamide antibiotics for at least 1 week prior to and during the 24-hour urine collection.
Who cannot join
- Current tobacco smoking
- History of a bleeding disorder
- Findings suggestive of cardiovascular disease.
- Blood pressure ≥ 145/90 mmHg after 10 minutes of rest on two or more screening visits, or treatment with three or more antihypertensive agents at any blood pressure.
- Fasting glucose ≥ 165 mg/dL, glycosylated hemoglobin > 8%, or any treatment with oral hypoglycemic agents, insulin sensitizing agents , insulin, incretin mimetics, amylin analogues, or endocannabinoid receptor antagonists.
- 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.
Show all 29Show fewer
- Current treatment with weight loss medications.
- History of bariatric surgery
- Current treatment with any cholesterol-lowering medications.
- Hyperthyroidism or untreated hypothyroidism.
- Pregnancy, desired pregnancy, or lactation within the study period.
- Peri- or postmenopausal status.
- Obstructive sleep apnea.
- Active gallstone disease
- Known history of chronic hepatitis, or liver enzymes 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
- Renal disease, as evidenced by a serum creatinine above the normal limit on more than one screening visit
- 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 or a history of medical or psychological treatment for an eating disorder
- Severe binge eating disorder
- Active moderate to severe depression.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10021
About this study
Official title: Dietary Interventions for Insulin Resistance and the Metabolic Syndrome
Current estimates suggest that 65% of American adults are overweight or obese. Excess body weight has been associated with an increased risk of a number of metabolic abnormalities, including high blood sugar, high blood pressure, high triglyceride levels, and low HDL ("good") cholesterol levels. Insulin resistance (when the body becomes less sensitive to the blood sugar-lowering hormone insulin, and more of the hormone is needed to keep blood sugar levels under control) also frequently occurs as a result of excess body weight. These abnormalities can all increase the risk of heart disease and other serious medical problems. Individuals who are overweight often have a number of these abnormalities at the same time, a situation which is often called "the metabolic syndrome." Dietary changes, physical activity, and weight loss can lead to improvements in each of the metabolic abnormalities described above. However, the best type of diet for people with the metabolic syndrome is not known. This study has been designed to test the effects of several promising dietary patterns, with and without weight loss, in overweight adults with the metabolic syndrome. Most individuals who have the metabolic syndrome do not know they have the condition, so we will be screening many healthy overweight volunteers to see if they may be eligible.
Read the detailed description
BACKGROUND:
Several dietary approaches, including the Dietary Approaches to Stop Hypertension study diet (the DASH diet) and the low glycemic index diet (low GI diet), may be helpful for overweight individuals who have the metabolic syndrome. The DASH diet is rich in fruits, vegetables, whole grains, and low-fat dairy products. It also contains moderate amounts of nuts, beans, fish, and poultry. Consumption of red meat, sweets, and sugary beverages is limited. As a result, the DASH diet contains more potassium, magnesium, calcium, and fiber and less total fat, saturated fat, cholesterol, simple sugars, and sodium than the average American diet. The DASH diet has been shown to lower blood pressure and LDL cholesterol ("bad" cholesterol). It has also been shown to be an effective diet for weight loss. It may also reduce inflammation and insulin resistance, two important features of the metabolic syndrome.
Low GI diets are typically lower in carbohydrate content and higher in protein content than the average American diet. Many popular diet books promote the use of low glycemic index diets. In this study, the low GI diet will contain plenty of fruits and vegetables and moderate amounts of nuts, beans, lean meats, fish, and reduced-fat dairy products. Refined grains, potatoes, and sweets will be avoided. The low GI diet can help improve levels of blood sugar and insulin in the blood after meals. It may also help control hunger after meals. Some researchers believe it may promote more weight loss than other diets, especially in people with the metabolic syndrome. The low GI diet may also reduce cholesterol and triglyceride levels.
Although both the DASH diet and the low GI diet appear to have beneficial effects, it is not clear whether one diet is better than the other for people with the metabolic syndrome. It is also not clear whether these diets would be better for weight loss than a reduced-calorie average American diet. This weight loss study has been designed to test the metabolic effects of the DASH diet and the low GI diet, as compared to the average American diet.
STUDY OVERVIEW:
Up to 18 research volunteers will be studied at Rockefeller University Hospital during a multi-phase study of almost 15 weeks duration. This study includes a 2-week run-in period at home, a 19-day inpatient period during which weight will be kept stable, an 8-week outpatient weight loss period, and a 2-week inpatient period of weight stability at a lower body weight. All food will be provided for about 13 weeks (during the inpatient periods and the 8-week outpatient weight loss period). Volunteers will first undergo testing (described below) at baseline, on an average American diet. They will then be randomized to one of three diets (the DASH diet, the low GI diet, or the average American diet). Weight will initially be kept stable for two weeks on the study diet. At the end of the first inpatient period, volunteers will undergo repeat testing to assess the metabolic effects of the diets, in the absence of weight loss. Volunteers will then be discharged to home for 8 weeks, during which they will receive a 50% reduced-calorie study diet. Volunteers will return to Rockefeller University Hospital twice a week during the outpatient phase for weight-management skills training and follow-up with study staff. It is expected that volunteers will lose between 5 and 9% of their starting weights during this time. At the end of the weight loss phase, volunteers will be readmitted to the research hospital for a final 2-week stay. Body weight will be maintained at the new, lower weight, and volunteers will undergo repeat testing on the study diet. At the conclusion of testing, volunteers will be discharged from the hospital and the study will conclude.
TESTING:
During this study, a number of tests and procedures will be performed at various times. These will include:
- Questionnaires about physical activity, eating habits, attitudes about food, quality-of-life, and hunger
- A 3-day record of food intake at baseline
- Use of a pedometer (step-counter) to assess usual physical activity
- Blood tests (including blood sugar, insulin levels, cholesterol levels, fat hormones, and inflammatory markers)
- 24-hour ambulatory blood pressure monitoring
- Measurement of energy expenditure (the rate at which a body burns calories)
- Noninvasive assessment of body composition before and after weight loss
- Insulin clamp procedures (during which insulin and sugar are infused through a vein to help determine how sensitive a person's body is to insulin)
- Conditions
- Metabolic Syndrome X, Obesity, Insulin Resistance, Hypertension, Diabetes
- Being tested
- The DASH diet, The low glycemic Index Diet, Reduced calorie American Diet
- Keywords
- Weight loss, Obesity, Metabolic Syndrome, Diet, Hypertension, Diabetes, Cholesterol
- Medical subject headings
- Metabolic Syndrome, Obesity, Insulin Resistance, Hypertension, Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The DASH dietBehavioural
The DASH diet was originally conceived as the optimal diet for individuals with hypertension, based on epidemiologic and clinical trial data suggesting a beneficial effect of plant-based diets on blood pressure It is a diet rich in fruits, vegetables, whole grains, and low-fat dairy products, with moderate amounts of nuts, legumes, fish, and poultry. Consumption of red meat, sweets, and sugary beverages is limited. As a result, the DASH diet contains more potassium, magnesium, calcium, and fiber and less total fat, saturated fat, cholesterol, simple sugars, and sodium than the average American diet
The low glycemic Index DietBehavioural
The carbohydrate content of a low GI diet can vary, but many advocates of low GL popular diets suggest a macronutrient profile that is 40% carbohydrate, 30% protein, and 30% fat. These low GL diets are lower in carbohydrate content and higher in protein content than the average American diet. Low GL diets typically contain ample amounts of fruits and vegetables, moderate quantities of nuts, legumes, lean meats, fish, and reduced-fat dairy products, and scant amounts of refined grains, potatoes, and sweets
Reduced calorie American DietBehavioural
The reduced-calorie diets will provide at least the Recommended Daily Allowance (RDA) for protein (0.8 g/kg/day).
| Study group | Role | What they receive |
|---|---|---|
| Average American Diet | Active comparator | Not described Receives: Behavioral: Reduced calorie American Diet |
| The DASH diet | Active comparator | Not described Receives: Behavioral: The DASH diet |
| The Low Glycemic Index Diet | Active comparator | The carbohydrate content of a low GI diet can vary, but many advocates of low GL popular diets suggest a macronutrient profile that is 40% carbohydrate, 30% protein, and 30% fat. These low GL diets are lower in carbohydrate content and higher in protein content than the average American diet. Low GL diets typically contain ample amounts of fruits and vegetables, moderate quantities of nuts, legumes, lean meats, fish, and reduced-fat dairy products, and scant amounts of refined grains, potatoes, and sweets Receives: Behavioral: The low glycemic Index Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity over time
Measured: Baseline, Inpatient Days 1-19, Inpatient final 2 weeks
Secondary outcomes (6)
Change in body weight
Measured: Baseline, Outpatient 2 weeks, inpatient 1-19 days, outpatient 8 weeks and inpatient 2 weeks
Change in blood sugar levels
Measured: baseline and final inpatient 2 weeks
Change in blood pressure
Measured: Baseline, Inpatient days 1-19 and inpatient 2 weeks
Change in cholesterol levels
Measured: Baseline and outpatient 8 weeks
Change in inflammatory markers
Measured: Baseline, Inpatient days 1-19 and outpatient 2 weeks
Diet satisfaction
Measured: day 88
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Neff, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422630
- Sponsor's protocol ID
- LNE 595-0107
- Status last verified
- Oct 2011
- First submitted
- 12 Jan 2007
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Interventions for Insulin Resistance and the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00422630
- Acronym / sponsor ID
- LNE 595-0107
- Conditions
- Metabolic Syndrome X, Obesity, Insulin Resistance, Hypertension, Diabetes
- Keywords
- Weight loss, Obesity, Metabolic Syndrome, Diet, Hypertension, Diabetes, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 Jan 2007 (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.
Current estimates suggest that 65% of American adults are overweight or obese. Excess body weight has been associated with an increased risk of a number of metabolic abnormalities, including high blood sugar, high blood pressure, high triglyceride levels, and low HDL ("good") cholesterol levels. Insulin resistance (when the body becomes less sensitive to the blood sugar-lowering hormone insulin, and more of the hormone is needed to keep blood sugar levels under control) also frequently occurs as a result of excess body weight. These abnormalities can all increase the risk of heart disease and other serious medical problems. Individuals who are overweight often have a number of these abnormalities at the same time, a situation which is often called "the metabolic syndrome." Dietary changes, physical activity, and weight loss can lead to improvements in each of the metabolic abnormalities described above. However, the best type of diet for people with the metabolic syndrome is not known. This study has been designed to test the effects of several promising dietary patterns, with and without weight loss, in overweight adults with the metabolic syndrome. Most individuals who have the metabolic syndrome do not know they have the condition, so we will be screening many healthy overweight volunteers to see if they may be eligible.
Detailed description
BACKGROUND:
Several dietary approaches, including the Dietary Approaches to Stop Hypertension study diet (the DASH diet) and the low glycemic index diet (low GI diet), may be helpful for overweight individuals who have the metabolic syndrome. The DASH diet is rich in fruits, vegetables, whole grains, and low-fat dairy products. It also contains moderate amounts of nuts, beans, fish, and poultry. Consumption of red meat, sweets, and sugary beverages is limited. As a result, the DASH diet contains more potassium, magnesium, calcium, and fiber and less total fat, saturated fat, cholesterol, simple sugars, and sodium than the average American diet. The DASH diet has been shown to lower blood pressure and LDL cholesterol ("bad" cholesterol). It has also been shown to be an effective diet for weight loss. It may also reduce inflammation and insulin resistance, two important features of the metabolic syndrome.
Low GI diets are typically lower in carbohydrate content and higher in protein content than the average American diet. Many popular diet books promote the use of low glycemic index diets. In this study, the low GI diet will contain plenty of fruits and vegetables and moderate amounts of nuts, beans, lean meats, fish, and reduced-fat dairy products. Refined grains, potatoes, and sweets will be avoided. The low GI diet can help improve levels of blood sugar and insulin in the blood after meals. It may also help control hunger after meals. Some researchers believe it may promote more weight loss than other diets, especially in people with the metabolic syndrome. The low GI diet may also reduce cholesterol and triglyceride levels.
Although both the DASH diet and the low GI diet appear to have beneficial effects, it is not clear whether one diet is better than the other for people with the metabolic syndrome. It is also not clear whether these diets would be better for weight loss than a reduced-calorie average American diet. This weight loss study has been designed to test the metabolic effects of the DASH diet and the low GI diet, as compared to the average American diet.
STUDY OVERVIEW:
Up to 18 research volunteers will be studied at Rockefeller University Hospital during a multi-phase study of almost 15 weeks duration. This study includes a 2-week run-in period at home, a 19-day inpatient period during which weight will be kept stable, an 8-week outpatient weight loss period, and a 2-week inpatient period of weight stability at a lower body weight. All food will be provided for about 13 weeks (during the inpatient periods and the 8-week outpatient weight loss period). Volunteers will first undergo testing (described below) at baseline, on an average American diet. They will then be randomized to one of three diets (the DASH diet, the low GI diet, or the average American diet). Weight will initially be kept stable for two weeks on the study diet. At the end of the first inpatient period, volunteers will undergo repeat testing to assess the metabolic effects of the diets, in the absence of weight loss. Volunteers will then be discharged to home for 8 weeks, during which they will receive a 50% reduced-calorie study diet. Volunteers will return to Rockefeller University Hospital twice a week during the outpatient phase for weight-management skills training and follow-up with study staff. It is expected that volunteers will lose between 5 and 9% of their starting weights during this time. At the end of the weight loss phase, volunteers will be readmitted to the research hospital for a final 2-week stay. Body weight will be maintained at the new, lower weight, and volunteers will undergo repeat testing on the study diet. At the conclusion of testing, volunteers will be discharged from the hospital and the study will conclude.
TESTING:
During this study, a number of tests and procedures will be performed at various times. These will include:
- Questionnaires about physical activity, eating habits, attitudes about food, quality-of-life, and hunger
- A 3-day record of food intake at baseline
- Use of a pedometer (step-counter) to assess usual physical activity
- Blood tests (including blood sugar, insulin levels, cholesterol levels, fat hormones, and inflammatory markers)
- 24-hour ambulatory blood pressure monitoring
- Measurement of energy expenditure (the rate at which a body burns calories)
- Noninvasive assessment of body composition before and after weight loss
- Insulin clamp procedures (during which insulin and sugar are infused through a vein to help determine how sensitive a person's body is to insulin)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Average American Diet | Active comparator | Behavioral: Reduced calorie American Diet |
| The DASH diet | Active comparator | Behavioral: The DASH diet |
| The Low Glycemic Index Diet | Active comparator | Behavioral: The low glycemic Index DietThe carbohydrate content of a low GI diet can vary, but many advocates of low GL popular diets suggest a macronutrient profile that is 40% carbohydrate, 30% protein, and 30% fat. These low GL diets are lower in carbohydrate content and higher in protein content than the average American diet. Low GL diets typically contain ample amounts of fruits and vegetables, moderate quantities of nuts, legumes, lean meats, fish, and reduced-fat dairy products, and scant amounts of refined grains, potatoes, and sweets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Nonsmoking men and premenopausal women, ages 18-45
- Body mass index ≥ 27 kg/m2
- Body weight < 200 kg
- Evidence of insulin resistance, as suggested by any one of the following:
- Fasting glucose ≥ 100 mg/dL
Key exclusion criteria (29 listed)
- Current tobacco smoking
- History of a bleeding disorder
- Findings suggestive of cardiovascular disease.
- Blood pressure ≥ 145/90 mmHg after 10 minutes of rest on two or more screening visits, or treatment with three or more antihypertensive agents at any blood pressure.
- Fasting glucose ≥ 165 mg/dL, glycosylated hemoglobin > 8%, or any treatment with oral hypoglycemic agents, insulin sensitizing agents , insulin, incretin mimetics, amylin analogues, or endocannabinoid receptor antagonists.
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 |
|---|---|---|
| The DASH dietThe DASH diet was originally conceived as the optimal diet for individuals with hypertension, based on epidemiologic and clinical trial data suggesting a beneficial effect of plant-based diets on blood pressure It is a diet rich in fruits, vegetables, whole grains, and low-fat dairy products, with moderate amounts of nuts, legumes, fish, and poultry. Consumption of red meat, sweets, and sugary beverages is limited. As a result, the DASH diet contains more potassium, magnesium, calcium, and fiber and less total fat, saturated fat, cholesterol, simple sugars, and sodium than the average American diet | Behavioural | The DASH diet |
| The low glycemic Index DietThe carbohydrate content of a low GI diet can vary, but many advocates of low GL popular diets suggest a macronutrient profile that is 40% carbohydrate, 30% protein, and 30% fat. These low GL diets are lower in carbohydrate content and higher in protein content than the average American diet. Low GL diets typically contain ample amounts of fruits and vegetables, moderate quantities of nuts, legumes, lean meats, fish, and reduced-fat dairy products, and scant amounts of refined grains, potatoes, and sweets | Behavioural | The Low Glycemic Index Diet |
| Reduced calorie American DietThe reduced-calorie diets will provide at least the Recommended Daily Allowance (RDA) for protein (0.8 g/kg/day). | Behavioural | Average American Diet |
Primary outcome
Change in insulin sensitivity over time
Time frame: Baseline, Inpatient Days 1-19, Inpatient final 2 weeks
6 secondary outcomes
Change in body weight
Time frame: Baseline, Outpatient 2 weeks, inpatient 1-19 days, outpatient 8 weeks and inpatient 2 weeks
Change in blood sugar levels
Time frame: baseline and final inpatient 2 weeks
Change in blood pressure
Time frame: Baseline, Inpatient days 1-19 and inpatient 2 weeks
Change in cholesterol levels
Time frame: Baseline and outpatient 8 weeks
Change in inflammatory markers
Time frame: Baseline, Inpatient days 1-19 and outpatient 2 weeks
Diet satisfaction
Time frame: day 88
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 13 Oct 2011.
Related trials for Metabolic Syndrome X
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Obesity, Metabolic Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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
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 The DASH diet, The low glycemic Index Diet and Reduced calorie American Diet in people with Metabolic Syndrome X and 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 19 inclusion and 29 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 13 Oct 2011. 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 over time (time frame: Baseline, Inpatient Days 1-19, Inpatient final 2 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 13 Oct 2011.