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: 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
B: Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.
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: (Intervention study)

Inclusion Criteria:

Subjects were considered eligible if they were 45 years old or older but younger than 70 years old at study entry, had type 2 diabetes and met both "(1) and (2)" or both "(1) and (3)" described below. \[Note: Those who met all three "(1), (2) and (3)" were also considered eligible for inclusion.\](1) Glycemic control Those with HbA1c 6.9% or greater despite treatment with any of the three regimens given below. Diet and exercise therapy alone, Diet and exercise therapy plus 1 oral anti-diabetic drug, Diet and exercise therapy plus, GI and 1 other oral anti-anti-diabetic drug (2) Blood pressure control Those with the following casual blood pressure (BP) level as measured on an outpatient basis, Systolic BP 140 mmHg or diastolic BP 90 mmHg while not on an antihypertensive agent, Systolic BP 130 mmHg or diastolic BP 80 mmHg while on 1 or 2 ARB, ACEI or long-acting CCB Those receiving antihypertensive agents other than ARB, ACEI or long-acting CCB were not eligible for study entry, with the exception of those who were receiving these agents for other purposes than blood pressure lowering. (3) Lipid metabolism Those with the following fasting lipid levels while not on a lipid-lowering agent LDL-cholesterol, 120 mg/dL (as calculated by using the Friedewald formula) Triglycerides, 150 mg/dL HDL-cholesterol, \< 40 mg/dL Subjects receiving 1 lipid-lowering agent were judged eligible for study entry if they met any of the above criteria. However, care needs to be taken to ensure that those on fibrates discontinue the fibrate treatment at the start of the study when they are assigned to the intensive therapy arm.

Exclusion Criteria:

1. Those with poorly controlled hypertension despite pharmacological therapy (systolic BP 200 mmHg or diastolic BP 120 mmHg) 2. Those on insulin therapy 3. Those with non-diabetic renal disease 4. Those in whom type 1 and other diabetes due to pathogenic mechanisms other than those associated with type 2 diabetes is strongly suspected 5. Those who tested anti-GAD antibody\*-positive 6. Those with LDL-cholesterol 200 mg/dL 7. Those suspected of having secondary hypertension other than renal parenchymal hypertension 8. Those suspected of having hereditary lipid disorder with a strong family history of lipid metabolic disorder 9. Those who were receiving antihypertensive agents other than ARB, ACEI, long-acting CCB, except where they were receiving these agents for other purposes than blood pressure lowering 10. Those who were receiving 3 or more antihypertensive agents (i.e., ARB, ACEI, and long-acting CCB), except where they were receiving these agents for other purposes than blood pressure lowering 11. Those with more serious retinopathy than proliferative retinopathy 12. Renal failure (serum Cr: 2.0 mg/dL in men; 1.5 mg/dL in women) 13. Those with a history of cardiac failure or those with cardiac failure 14. Those who were pregnant or potentially pregnant 15. Those who met any of the following criteria and who had BNP 100 pg/mL, Myocardial infarction, Angina pectoris (or a history of disease), History of coronary artery bypass graft (CABG), History of percutaneous coronary angioplasty (PTCA), Other cardiac disease, ECG findings of left ventricular hyperplasia, Abnormal ECG findings (excluding isolated extrasystole or right bundle branch block \[RBBB\]) 16. Those judged by the physician in charge to be ineligible for study entry

(Follow-up study)

Inclusion criteria:

Of the subjects in the randomized controlled study comparing intensive therapy and conventional therapy in type 2 diabetic patients (J-DOIT3), those who provide written informed consent to participate in the follow-up study will be enrolled regardless of completion or discontinuation from the randomized controlled study (If the subject is unable to provide informed consent for any reason, consent from his/her legal representative is allowed).

Exclusion criteria:

A subject who is assessed as ineligible by the investigator will be excluded from the follow-up study

Answer: C