Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease
Brief Summary: In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes (T2DM). More recently, this aspect of treatment has received less attention as drug therapy aimed not only to lower glucose, but also to treat raised blood pressure and blood fats (including cholesterol) has been more widespread. While there is evidence to suggest that blood pressure and blood fat levels have improved, overall diabetes control has not and people with diabetes appear to be becoming progressively more overweight, following trends in the general population. The proposed study involves a randomised controlled trial in which people with T2DM continuing with their regular drug treatment and surveillance, will be randomly allocated to additionally receive intensive advice regarding diet or remain on their usual treatment in this regard. The results will be judged principally in terms of body weight, waist circumference, blood pressure, blood glucose control and blood fats.


Options:
A: Inclusion Criteria:

* The subjects had impaired fasting glycemia (fasting plasma glucose concentration 5.6-7.0 mmol/L) or impaired glucose tolerance (2-hour plasma glucose concentration 7.8-11.0 mmol/L)
* AND at least 2 other features of the metabolic syndrome according to the Adult Treatment Panel III criteria as modified by the AHA:
* waist circumference \>102 cm (males)/ \>88 cm (females)
* fasting serum triacylglycerol concentration \>1.7 mmol/L
* fasting serum HDL-cholesterol \<1.0 mmol/L (males) / \<1.3 mmol/L (females)
* blood pressure \>130/80 mmHg.

Exclusion Criteria:

* liver, kidney and thyroid dysfunction
B: 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
C: Inclusion Criteria:

* Willing to sign a consent form.
* BMI during screening ≥25 kg/m2 (eligibility for weight loss support group)
* Participants must not have had any surgical procedures influencing weight regulation to include, but not limited to, gastric bypass, other bariatric surgeries, resection of small or large intestine leading to malabsorption, gastric resection for ulcers or cancer, and esophageal resection
* Intention to follow recommended program and complete outcome assessments and requested self-monitoring.
* Obtain a physician's clearance form
D: DISEASE CHARACTERISTICS:

* At increased risk for developing breast cancer due to any of the following lifestyle risk factors:

  * Lack of physical activity
  * Excess weight
  * Obesity
  * Weight gain over lifetime
* Body mass index \> 25.0
* Physically able to undertake a moderate exercise or calorie reduction program
* No history of invasive or in situ breast cancer

PATIENT CHARACTERISTICS:

* Postmenopausal, defined by the absence of periods for the past 12 months
* Able to attend study clinic visits and classes, and undergo study measurements
* Able to fill out questionnaires and logs in English
* No moderate to high alcohol intake (more than 2 drinks per day)
* No concurrent smoking
* No invasive cancer within the past 10 years except simple basal cell or squamous cell carcinoma
* No diabetes mellitus

  * Fasting blood sugar \< 126 mg/dL (on 2 occasions)
* Hematocrit 32-48%
* WBC 3,000-15,000/mm³
* Potassium 3.5-5.0 mEq/L
* Creatinine ≤ 2.0 mg/dL
* No abnormalities on screening physical that contraindicate study participation
* No contraindications for treadmill testing or entry into a training program, including any of the following:

  * Myocardial infarction within the past 6 months
  * Pulmonary edema
  * Myocarditis
  * Pericarditis
  * Unstable angina
  * Pulmonary embolism or deep vein thrombosis
  * Uncontrolled hypertension (i.e., blood pressure \> 200/100 mm Hg)
  * Orthostatic hypotension
  * Moderate-to-severe aortic stenosis
  * Uncontrolled arrhythmia
  * Uncontrolled congestive heart failure
  * Third-degree heart block
  * Left bundle branch block
  * Thrombophlebitis
  * ST depression \> 3 mm at rest
  * History of cardiac arrest or stroke
* Normal exercise treadmill testing (ETT)

  * Negative thallium or echo ETT required for patients with abnormal ETT (defined as ≥ 1.5 mm ST depression in \> 1 lead within 1-minute recovery OR ≥ 1.1 mm ST depression in \> 1 lead after 1-minute recovery OR reading of positive test by study doctor)
* No drug abuse
* No significant mental illness

PRIOR CONCURRENT THERAPY:

* More than 6 months since prior and no concurrent menopausal hormone replacement therapy of any type, including vaginal route
* No concurrent participation in any other organized weight loss or exercise program
* No concurrent appetite suppressant medication
* No concurrent medications (e.g., weight-loss medications) likely to interfere with adherence to interventions or study outcomes

Answer: B