Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
Brief Summary: The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.


Options:
A: Inclusion Criteria:

* Age: 16-35 years
* Body mass index (kg/m2): 28-36

Exclusion Criteria:

* Body weight fluctuations \> 3 kg over the previous 2 months
* Smoking

Presence of:

* Cardiovascular diseases, cancer tumours, kidney or lever diseases, infections or endocrinological diseases, malabsorption disorders
* Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg
* Hypercholesterolemia with changes in pharmacological treatment within the last 2 months
* Regular use of medicine other than birth pills, any psychological disorders, known or presumed abuse of alcohol, allergies to any food, special diets (eg. vegetarian) or particular dislikes
* Pregnancy, lactating or planning pregnancy within 18 month from enrolment
B: Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus

Exclusion Criteria:

* hemoglobin A1c values \<6.5% or \>10.5%
* use of insulin for \> 5 years
* tobacco use within the preceding 6 months
* consumption of more than 2 alcoholic beverages per day
* current drug abuse
* pregnancy
* unstable medical status
* current use of a low-fat, vegetarian diet.
C: DISEASE CHARACTERISTICS: Primary operable stage I (tumors at least 1 cm), stage II, and stage IIIA invasive breast carcinoma Treatment within the past 4 years by total mastectomy and axillary dissection, or breast sparing surgical removal of cancer with clear macroscopic margins and axillary dissection followed by adjuvant breast radiation No evidence of recurrent disease or new breast cancer since completion of initial local treatment confirmed within the past 6 months by physician evaluation, except stage I mastectomy, for which physician evaluation can be within 1 year prior to randomization Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 70 at time of diagnosis Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: At least 10 years (excluding breast cancer) Hematopoietic: Not specified Hepatic: No cirrhosis Renal: Not specified Other: Not pregnant Accessible geographically and by telephone Able to communicate dietary data via 24-hour food recall Able to commit to the intervention schedule No comorbidity requiring a specific diet or taking a medication which contraindicates consuming a high fiber diet (e.g., systemic scleroderma, other digestive malabsorption syndromes, and insulin dependent diabetes) No other primary or recurrent invasive cancer within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent estrogen replacement therapy, including vaginal estrogen creams Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent enrollment in another clinical trial that has dietary restrictions or endpoints similar to this study
D: Inclusion Criteria:

* BMI of 27-40 kg/m2
* 30-75 years of age
* Stable body weight for the preceding 6 months
* Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
* HbA1c of 6.5 to 9.0
* Treatment by diet or oral agents only

Exclusion Criteria:

* Pregnancy or lactation
* Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
* Untreated thyroid disease or hypertension
* Hypertriglyceridemia with levels of TG \> 500 mg/dl
* Use of insulin
* Use of specific medications that may alter lipid or glucose metabolism (other than the statins)
* Use of medications that commonly cause significant alterations in body weight (e.g., corticosteroids).

Answer: D