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临床试验/NCT02260895
NCT02260895终止不适用

Almond Effects on Glucose Intolerance Study (AEGIS)

Memorial Hermann Health System2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
2
主要终点
One-hour OGTT result

研究概览

简要总结

Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an important goal. The progression from impaired glucose tolerance to diabetes is thought to be promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is reduced first phase (immediate) insulin release. The investigators hypothesis is that consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and synthesis.

The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with the timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).

The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40 mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to show a statistically significant difference between the almond pre-test snack and control standard OGTT conditions.

详细描述

The study will be conducted at Physicians at Sugar Creek (PSC)-the model family practice center for the Memorial Family Medicine Residency Program. The ethnicity of PSC patients is approximately 30% non-Hispanic white, 30% Hispanic, 30% African-American, and 10% Asian.

Potential participants will be identified by searching PSC electronic medical records (Centricity) to find adults aged 18-75 with impaired glucose tolerance, without diabetes (one-hour oral glucose tolerance test result >160 md/dl and two-hour OGTT result <200 mg/dl), without hypoglycemic medications and corticosteroids on their active medications list, and without almond allergy on their allergy list.

Recruitment flyers will be posted in the clinic to encourage interested individuals to contact the investigators about their potential study eligibility. The investigators will also approach previously identified potentially eligible patients during routine clinical visits in the clinic, to elicit their interest in participating in the study. Those expressing interest will be scheduled for an intake visit with an investigator, to further ascertain their eligibility and invite eligible individuals to take part in the study. Interested eligible individuals who render verbal and written informed consent will then be instructed in the study protocol and scheduled for their first data gathering visit.

Each participant will be scheduled to undergo two 2-hour oral glucose tolerance tests (OGTT), starting between 7:00 and 9:30 a.m., one to four weeks apart. Test A will be a standard 75-gram OGTT. Test B will be an OGTT that will begin 30 minutes after ingestion of a low-carbohydrate pre-load "snack" consisting of 1/2 oz (14 grams) of unsalted, dry-roasted almonds (12 average size almonds). Each participant will be given an 8-ounce glass of water to drink with the almonds. Participants will be randomized to one of two test sequences (A-B or B-A), to control for sequence effects on results.

To minimize variability of OGTT results, participants will be asked to eat as they usually do throughout the study. Participants will be asked to refrain from vigorous physical activity for 8 hours prior to each OGTT and to minimize their physical activity during each OGTT. Participants will complete a Perceived Stress Scale and a 24-hour food, alcohol, and activity recall for the day before each OGTT to analyze potential confounding effects of stress, diet, alcohol, and physical activity on the results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of abnormal 1-hour OGTT result (>160 mg/dL) or 2-hour OGTT (>140)

排除标准

  • History of a diagnosis of diabetes
  • History of a 2-hour OGTT result >200 mg/dL
  • History of a fasting glucose >125 mg/dL

结局指标

主要结局

One-hour OGTT result

时间窗: 60 minutes into 2-hour oral glucose tolerance test

One-hour oral glucose tolerance test result

次要结局

  • Two-hour OGTT result(120 minutes into 2-hour oral glucose tolerance test)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aryn Knight

AVP Research

Memorial Hermann Health System

研究点 (2)

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