Phase
Condition
Diabetes Mellitus, Type 2
Obesity
Diabetes Prevention
Treatment
Dietary
Other Fruit(s)
Avocado
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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'sdiabetes
Willing to give release to provide their treating MD with information about thetrial
Exclusion
Exclusion Criteria:
Not willing or unable to consume study foods including avocados
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
History of a surgical procedure for weight loss in last 5 years (e.g. gastroplasty,gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastricsleeve)
History of major surgery within three months of enrollment
Type 1 diabetes, insulin dependent type 2 diabetes, thiazolidinediones (includingrosiglitazone and pioglitazone)
Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzedspecimen, 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 emergencymedical services) in the past 12 months, unless the participant's treating physicianprovides written clearance for participation.
Those on higher doses of diuretics (furosemide 40mg or higher or comparable)
Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such asunstable angina, coronary ischemia)
Presence of implanted cardiac defibrillator
Blood pressure ≥180/100 mm Hg. If a potential participant has a BP above theinclusion criteria it is acceptable to re-test this potential participant within oneweek of the original test.
Thyroid disease for which the participant is untreated or has had treatment changedwithin the last 6 months. History of thyroid disease or current thyroid diseasetreated with a stable medication regimen for at least 6 months is acceptable
Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions,peptic ulcer disease, Crohn's disease, chronic diarrhea, or active gallbladderdisease
Current cancer or cancer treatment, or a history of cancer or cancer treatmentwithin the last 3 years. Persons with successfully resected non-melanoma carcinomaof 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)
Women who are pregnant, lactating, trying to become pregnant or unwilling to use aneffective 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
Participation in another clinical trial within 30 days prior to enrollment
Any other condition or factor which in the opinion of the study physician orinvestigator makes it inadvisable for the candidate to participate in the trial
Study Design
Connect with a study center
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
United StatesActive - Recruiting

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