Please select the eligibility criteria that correspond to the clinical trial below.
Title: EMPOWIR: Enhance the Metabolic Profile of Women With Insulin Resistance: Carbohydrate Modified Diet Alone and in Combination With Metformin or Metformin Plus Avandia in Non-diabetic Women With Midlife Weight Gain and Documented Insulin Elevations (Syndrome W)
Brief Summary: The goal of the study is to identify and treat women with midlife weight gain who have normal blood sugars, but increased insulin levels (hyperinsulinemia) following the performance of a glucose tolerance test. The study will evaluate effects of a unique carbohydrate modified diet alone and in combination with metformin(MF) and Avandamet® (MF plus rosiglitazone (RSG)) on insulin levels in a wide range of ethnically diverse women (aged 35-55) at three academic medical centers. The primary study hypothesis is that insulin sensitizing medications, in combination with alterations in carbohydrate intake, will reduce insulin levels and improve established risk factors for the metabolic syndrome.

The alarming prevalence of obesity, diabetes, and related comorbidities and the paucity of easily adopted, cost-effective preventive strategies for high risk populations, suggest that pharmaco-therapies and dietary regimens targeted to reducing insulin resistance could have important clinical and public health implications.


Options:
A: Inclusion Criteria:

* 18-40 years of age BMI \>=25 stable weight for 3 months non-vegetarian good understanding of English

Exclusion Criteria:

medications other than the contraceptive pill weight \>150kg (weight limit of DEXA machine) vegetarian (diets included red meat) specific diets diabetes or impaired glucose tolerance pregnancy

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B: Inclusion Criteria:

1. Healthy, non-diabetic women with "≥20 pound weight gain since their twenties"
2. Age: 35-55
3. Peri-menopausal or postmenopausal status
4. Body Mass Index (BMI) 25-35 kg/m2
5. Either:

   1. a single blood pressure recording ≥135/85 or the use of blood pressure medication OR
   2. HDL≤50mg/dl or triglycerides ≥150 mg/dl or the use of lipid modifying medication
6. Area-under-the-curve (AUC-)insulin level\>100mcgU/ml along with normal fasting (≤100 mg/dl) \& postprandial ((≤200 mg/dl) glucose determinations following a 75-gram standard oral glucose tolerance test.

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Exclusion Criteria:

1. known diabetes, fasting blood sugar ≥100 mg/dl or HbA-1-C≥6.0%
2. known hepatic disease or ALT\>40
3. known renal disease or creatinine ≥ 1.4
4. known severe pulmonary disease
5. chronic acidosis of any etiology
6. Congestive heart failure (NYS Category 1), treated or untreated
7. Cancer - active within 5 years
8. current alcoholism or other substance abuse
9. co-morbid psychiatric disorder, which in the opinion of the screening physician would require concomitant psychotherapy as part of obesity management
10. currently untreated thyroid abnormality (TSH≤0.2 or ≥4mIU/L)
11. pregnancy or contemplation of pregnancy
12. use of TZD or metformin within the past year
13. allergy to TZD or biguanide
14. use of FDA approved or alternate obesity agent within 6 months of the study
15. history of pseudotumor cerebri
16. other impairment, such as a history of medication noncompliance, which in the judgment of the screening clinician, would preclude active study participation.
17. history of known or suspected heart disease
C: Inclusion Criteria:

* Age: \> 18 years of age
* Women: Pre-menopausal (self-report) and \<50 years of age
* Men: \<50 years of age
* BMI (body mass index): 27-40 kg/m2 (need to lose \>10% body weight to achieve healthy BMI)
* Body weight stable for the last two months, and not actively on a weight loss plan
* No plans to move from the area over the next two years
* Available and able to participate in the evaluations and intervention for the study period
* Willing to accept random assignment
* To enhance study generalizability, people on medications not noted below as specific exclusions can
* participate if they have been stable on such medications for at least three months
* Ability and willingness to give written informed
* No known active psychiatric illness

Exclusion Criteria:

Subjects with the following conditions will be excluded (determined by self-report):

* Pregnant, lactating, within 6 months post-partum, or planning to become pregnant in the next 2 years
* Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications for any other indication
* Prevalent diseases: Malabsorption, renal or liver disease, active neoplasms, recent myocardial infarction (\<6 months)(patient self-report and, if available, review of labs from primary care provider)
* Smokers (because of effect on weight and lipids)
* History of serious arrhythmias, or cerebrovascular disease
* Uncontrolled hyper- or hypothyroidism (TSH not within normal limits)
* Medications: Lipid lowering, antihypertensive medications, and those known to affect weight/energy expenditure
* Excessive alcohol intake (self-reported, \>3 drinks/day)
* Musculoskeletal disorders precluding regular physical activity
* Unable to follow either of the two study diets for reasons of food allergies or other (e.g., vegan)
* Currently under psychiatric care, or taking psychiatric medications
* Inability to communicate effectively with study personnel
D: Inclusion Criteria:

* Age between 15 and 18 years (inclusive)
* Male or female of Chinese ethnicity
* Body mass index \>/= 95th percentile of Hong Kong local age- and sex-specific reference
* No major medical illness
* Not on any chronic medications
* Post-pubertal as ascertained by clinical assessment by endocrinologist
* Willingness to give written informed consent by participants and his/her parents/guardian

Exclusion criteria:

* Concurrent participation in any clinical trial, dietary intervention or weight loss program
* Concomitant intake of weight reducing agent
* Active and uncontrolled endocrine diseases including hypo- or hyperthyroidism, Cushing's syndrome, diabetes mellitus, etc.
* Significant renal impairment, defined as serum creatinine \>150 umol/L and/or estimated glomerular filtration rate \<60ml/min/1.73m2
* Significant liver impairment, defined as \>2 times upper limit of alanine aminotransferase and asparate aminotransferase levels
* Gastrointestinal problems that would prevent them from following the test diets
* Active malignant disease
* Pregnant or lactating
* Any medical illness or condition including known non-compliance, as judged by the investigators as ineligible to participate the study

Answer: B