NCT05958368招募中不适用
The Effects of Hass Avocados on Glycemic Control in Persons With Type 2 Diabetes: A Randomized Controlled Crossover Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Fasting Blood Glucose
研究概览
简要总结
The objective of this study is to assess the effects of Hass Avocados on glycemic control. The investigators hypothesize that Hass Avocado consumption will reduce fasting blood sugar compared to an isocaloric amount of other fruit during controlled feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators and outcome assessors will be blinded to study treatment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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, gastric sleeve)
- •History of major surgery within three months of enrollment
- •Type 1 diabetes, insulin dependent type 2 diabetes, thiazolidinediones (including rosiglitazone and pioglitazone)
- •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.
- •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 as unstable angina, coronary ischemia)
- •Presence of implanted cardiac defibrillator
- •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.
- •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
- •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)
- •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
- •Participation in another clinical trial within 30 days prior to enrollment
- •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
结局指标
主要结局
Fasting Blood Glucose
时间窗: Week 5 - Week 0
the primary outcomes are based on within subject concentration change scores
次要结局
- Fasting Insulin(Week 5 - Week 0)
- Fructosamine(Week 5 - Week 0)
- Glycated Albumin(Week 5 - Week 0)
研究者
John Apolzan
Associate Professor-Research
Pennington Biomedical Research Center
研究点 (2)
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