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:

* 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).
B: Inclusion Criteria:

* Only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area
* Between the ages of 30 - 70
* Willing to modify eating pattern according to instructions
* Overweight or obese and in good health with a BMI of 25-40
* Committed to a long-term weight loss and maintenance program
* Willing to attend multiple weight loss group sessions
* Willing to increase activity level

Exclusion Criteria:

* Pregnant, planning to become pregnant, or are breastfeeding
* Unwilling to participate in the schedule of group sessions and individual visits
* Unstable or recent onset of heart disease or any other serious illness
* Cannot change diet due to medical or other reasons
* Planning to leave the area prior to the anticipated end of participation
* Current participation in another clinical trial with an intervention that affects weight change
* Have diabetes that is treated with insulin or hypoglycemic oral medicines
* Diagnosis of psychiatric or emotional problems within 6 months of study
* Currently have an eating disorder
* Have hypothyroidism
* Have an unstable weight
C: 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
D: 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

Answer: C