Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients
Brief Summary: The major environmental factors that increase the risk of type 2 diabetes, presumably in the setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent overweight and obesity. The high rate of weight regain has limited the role of lifestyle interventions as an effective means of controlling glycemia long term. The aims of the present study were: 1) To compare the effectiveness and safety of two nutritional protocols - namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive overweight patients with type 2 diabetes mellitus. The primary aim of the study was the effect on hemoglobin A1c levels; secondary aims were time to introduction of the first hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with HbA1c \< 7%.


Options:
A: Inclusion Criteria:

* Type 2 diabetes
* Resident in Dunedin
* Aged \<70 years at the time of invitation to participate
* Most recent HbA1c level within the last 12 months ≥ 7%
* Currently prescribed oral tablets or insulin or both for glycaemic control AND three of the following: \*Any pre-existing cardiovascular disease defined as a past history of myocardial infarction, angina, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack; \*Currently prescribed antihypertensive medication; \*Currently prescribed lipid modifying medication; \*Body mass index ≥25

Exclusion criteria:

* Terminal illness
B: 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
C: Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.
D: Inclusion Criteria:

* Type 2 diabetes mellitus (ADA criteria)
* BMI (body mass index) \> 25 kg/M2
* Hemoglobin A1c (HbA1c) \< 11%; Blood pressure \< 160 (systolic) and 100 (diastolic) mm Hg
* Triglyceride levels \< 500 mg/dl.

Exclusion Criteria:

* Pregnancy or breast-feeding
* Previous use of insulin or oral antidiabetic drugs
* Investigational drug within the previous 3 months
* Use of agents affecting glycemic control (systemic steroids and weight loss drugs)
* Patients with history of alcohol or illicit drug abuse
* Patients with liver enzymes higher than three times the upper limit of normal
* Serum creatinine \> 1.4 mg/dl.

Answer: D