Northeast Iowa Family Practice Center
Family Practice Center - Health Care for the Individual and Family
Research Department

Current Studies

ACCOMPLISH Trial (High Blood Pressure)
Gallant 6 (Type II Diabetes)
LAF 237 (Diabetes- Type II)
Madeitt (Metabolic Syndrome)
PRoFESS study (Prevention of second stroke)


ACCOMPLISH TRIAL (High Blood Pressure)

Inclusion:

  • Hypertension plus
  • A history of heart attack, coronary bypass surgery, stroke or diabetes
  • Patients must be 60 years of age or older

Exclusion:

  • Angina (chest pain) within the last three months)
  • Stroke or transient ischemic attack (TIA) within the last three months
  • Heart attack, stroke or open heart surgery within the last three months
  • History of symptomatic heart failure
  • Any kind of malignancy/cancer (except skin cancer)
  • History of alcohol or drug abuse

Benefits of participation in the study:

  • $25.00 per scheduled visit completed ($250.00 for total of 11 visits over 3 to 4 years)
  • Free study medication, study related lab work, ECG's and physical exams

If you are interested in this study contact Pam Trenkamp,
Study Coordinator, at 319-272-2523


Gallant 6 (Type II Diabetes) ˆtop

Inclusion:

  • Men or women ages 18 years or older
  • HbA1c ≥ 7% for drug naïve patients and ≤ 10% for all patients at visit 1
  • Diagnosed with type 2 diabetes
  • Treated with diet alone or treatment with single oral agent or low doses of two agents

Exclusion:

  • Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes
  • NYHA heart failure Class III or IV, or unstable Class I or II
  • History of thyroid ophthalmopathy
  • History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma

Benefits of participation in the study:

  • $25.00 per scheduled visit completed ($325.00 for total of 13 visits in 36 weeks )
  • Free study medication, study related lab work, EKGs and physicals

If you are interested in this study contact Angie Bixby-Ellermann, Study Coordinator, at 319-272-2536


LAF 237 (Diabetes- Type II) ˆtop

Inclusion:

  • Male or female ages 18-80 years
  • Patient who have received sulfonylurea for at least three months and have been on a stable dose (at least 7.5 mg glyburide qd, at least 7.5 mg glipizide qd or at least 2 mg glimepiride qd) for at least 4 weeks prior to visit 1 Patients not already treated with glimepiride 4 mg qd must be willing to switch to that drug and dose at visit 1
  • Body mass index (BMI) in the range of 22-45 kg/m2 inclusive at visit 1
  • HbA1c in the range of 7.5 to 11% inclusive at visit 1

Exclusion:

  • A history of:
    1. Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly
    2. Acute metabolic diabetic complication such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
  • Congestive heart failure NYHA class III or IV.
  • Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
  • Liver disease such as cirrhosis or chromic active hepatitis
  • Known sensitivity to glimepiride

Benefits of participation in the study:

  • $25.00 per scheduled visit completed ($150.00 for total of 6 visits although there is a possibility of an extention with additional scheduled visits)
  • Free study medication, study related lab work, EKGs and physicals

If you are interested in this study contact Angie Bixby-Ellermann, Study Coordinator, at 319-272-2536


Madeitt (Metabolic Syndrome) ˆtop

Inclusion:

  • Male or female 18 to 75 years of age
  • Central obesity defined as: Males with a waist circumference of > 40 inches and Female with a waist circumference of > 35 inches
  • The average mean BP from visit 2 and visit 3 must meet the following blood pressure criteria: MSSBP of ≥ 130 mmHg but ≤ 160 mmHG and a MSDBP of ≥ 85 mmHg but ≤ 100 mmHg
  • At least of of the following criteria:
    1. Fasting plasma glucose between 5.6 and 6.9 mmol/l based on result of FPG drawn at visit 2
    2. Serum triglycerides > 150 mg/dL
    3. Serum HDL cholesterol < 40 mg/dL in males or serum HDL cholesterol <50 mg/dL in females

Exclusion:

  • Patients who have been taking a diuretic for 3 months prior to visit 1
  • Patients with a history of diabetes
  • History of stroke, TIA, or MI
  • Active and or treated malignancies within 12 months prior to visit 1 with the exception of basal cell or squamous cell carcinoma

Benefits of participation in the study:

  • $25.00 per scheduled visit completed ($200.00 for total of 8 visits )
  • Free study medication, study related lab work

If you are interested in this study contact Angie Bixby-Ellermann, Study Coordinator, at 319-272-2536


PRoFESS study (Prevention of second stroke) ˆtop

Inclusion:

  • History of ischemic stroke (lack of blood supply to the brain) within the last three months
  • Patients must be 55 years of age or older

Exclusion:

  • Hemorrhagic stroke (bleeding in the brain)
  • Current congestive heart failure
  • Known brain tumor
  • History of dementia
  • Stroke associated with a cardiovascular surgical procedure (carotid endarterectomy, angiogram or heart surgery)
  • History of allergy to Plavix© or Aggrenox©
  • Patients that are currently on treatment with Coumadin© or heparin
  • Any history of kidney or liver problems
  • Active peptic ulcer disease (heartburn)
  • History of heart attack or angina (chest pain) within the last three months

Benefits of participation in the study:

  • $25.00 per scheduled visit completed ($250.00 for total of 11 visits over 4 year period)
  • Free study medication, study related lab work

If you are interested in this study contact Pam Trenkamp, Study Coordinator, at 319-272-2523