Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes

Korábbi kezelés

• Participation in a weight control program within the past 3 months or weight loss of ≥ 5 kg in the previous 3 months
• Taking prescription or OTC weight loss medications within last 4 weeks
• Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
• Participation in another clinical trial within 30 days prior to enrollment

Más betegség

• History of a surgical procedure for weight loss in last 5 years (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
• History of major surgery within three months of enrollment
• Type 1 diabetes, insulin dependent type 2 diabetes, thiazolidinediones (including rosiglitazone and pioglitazone)
• Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia)
• Presence of implanted cardiac defibrillator
• Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea, or active gallbladder disease
• Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled.
• Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year)
• Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial

Laborértékek

• Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzed specimen, or a creatinine over 2.5 mg/dL
• Bilirubin over 3 (mg/dL) or an albumin less than 3 (g/dL)
• ALT > 3 (IU/L) times the upper limit of normal (normal range is 7-56)
• Evidence of more than 1 severe hypoglycemic event (episode requiring emergency medical services) in the past 12 months, unless the participant's treating physician provides written clearance for participation.

Egyéb

• Not willing or unable to consume study foods including avocados
• Those on higher doses of diuretics (furosemide 40mg or higher or comparable)
• Blood pressure ≥180/100 mm Hg. If a potential participant has a BP above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test.
• Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control
• Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to stop intake during study participation

• Participant reported diagnosis of Type 2 diabetes
• HbA1c between 5.7%-11% (inclusive) and / or fasting blood glucose of ≥ 100 mg/dL
• BMI 27-50 kg/m2 (inclusive)
• Age range - 18 - 65 years (inclusive)
• On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
• Willing to follow all requirements of study protocol including blood draws
• Under the care of a physician who will be responsible for managing the subject's diabetes
• Willing to give release to provide their treating MD with information about the trial