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Trial record 55 of 356 for:    diabetes and insulin resistance and open and active

Egg Consumption and Glycemic Control in Individuals With Pre- and Type II-diabetes

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ClinicalTrials.gov Identifier: NCT03272074
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Egg Nutrition Center
Information provided by (Responsible Party):
Bahram Arjmandi, Florida State University

Brief Summary:
The intent of this study is to examine the extent to which daily incorporation of egg into a diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is that the daily incorporation of one large egg into a diet for 12 weeks will exert positive effects on factors associated with glycemic control and insulin sensitivity in overweight and obese adults with pre- and type II-diabetes through improvements in body weight, body composition, and lipid metabolism.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Obesity Pre Diabetes Other: Egg and egg white Not Applicable

Detailed Description:
Pre-diabetes is a condition that is characterized by elevated fasting blood glucose levels secondary to insulin resistance; however, fasting blood glucose levels are not elevated to the extent where it can be classified as type II-diabetes. Pre-diabetes may lead to type II-diabetes and is estimated to do so at an annual rate of approximately 10% in the United States (US) where approximately 79 million individuals have been diagnosed with pre-diabetes. In addition, most of the individuals presenting with pre-diabetes are overweight or obese, which makes long-term weight management an essential component in reducing the development of diabetes. Eggs are a rich source of important nutrients such as vitamins, minerals, proteins, carotenoids, choline, and lecithin. Many of the nutrients found in eggs function as antioxidants or as an essential component of antioxidants. Several studies have demonstrated that the onset and progression of diabetes are associated with increased oxidative stress. In vitro studies have shown that high-density lipoprotein (HDL) acts as a buffer mechanism for oxidative stress and inflammation due to its antioxidant effects. Thus, high blood levels of HDL may reduce insulin resistance and subsequently the development of type II-diabetes through its antioxidant and anti-inflammatory effects. Additionally, HDL can exert beneficial effects on glucose levels through the apolipoprotein A-1 (Apo A) action which increases glucose uptake by increasing insulin secretion in pancreatic beta cells. Because the development of diabetes involves an interaction between genetic predisposition and environmental factors including and excessive body weight, and eggs have been shown to positively influence body composition, we believe that eggs can improve glycemic control, insulin sensitivity, and lipid profiles through improvements in weight and body composition. To our knowledge, there have not been any studies investigating the effects of dietary egg consumption on improving glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetics. Our long-term goal is to bring forth evidence that the regular consumption of eggs is effective in reducing insulin resistance and subsequently the incidence of pre-diabetes and type II-diabetes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Egg Consumption Positively Affects Glycemic Control and Insulin Sensitivity in Individuals With Pre- and Type II-diabetes
Actual Study Start Date : September 11, 2015
Actual Primary Completion Date : September 7, 2016
Actual Study Completion Date : August 5, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Egg Group (Group A)
Participants will consume one large egg per day for 12 weeks
Other: Egg and egg white
Participants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities.

Active Comparator: Egg White Group (Group B)
Participants will consume equivalent amounts of egg whites for 12 weeks
Other: Egg and egg white
Participants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities.




Primary Outcome Measures :
  1. Fasting blood glucose, insulin resistance, and insulin sensitivity [ Time Frame: 12 weeks ]
    Commercially available enzyme-linked immunosorbent assay (ELISA) kits will be used to measure fasting blood glucose levels (mg/dL.). Insulin levels will be measured using a commercially available ELISA kit (mg/dL). blood glucose and insulin level measurements will be used to calculate Insulin sensitivity and insulin resistance will be measured using HOMA-IR and HOMA-β using the HOMA2 Calculator v2.2.2


Secondary Outcome Measures :
  1. Lipid panel [ Time Frame: 12 weeks ]
    ELISA kits will be used to measure the lipid panel parameters (mg/dL)


Other Outcome Measures:
  1. Body composition [ Time Frame: 12 weeks ]
    A certified operator will obtain DXA scans of each subject using DXA (GE Healthcare Lunar, Madison, WI, U.S.).

  2. ABCA1 Protein [ Time Frame: 12 weeks ]
    ELISA kits will be used to measure the ABCA1 protein (mg/dL)



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Overweight and obese, BMI is between 25 kg/m2 and 45 kg/m2
  • With pre- and type II-diabetes. Subjects will be eligible if their Hgb A1c level is >5.6%

Exclusion Criteria:

  • Subjects with BMI≤ 24 or ≥46 kg/m2
  • Uncontrolled hypertension (≥160/100 mmHg), active cancer, asthma, thyroid, glaucoma, kidney, liver and pancreatic diseases will be excluded from the study.
  • Subjects who are participating in any weight loss program and/or are heavy smokers (more than 20 cigarettes per day) will be excluded from the study.
  • Subjects who are allergic to egg and egg products will also be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272074


Locations
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United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
Egg Nutrition Center
Investigators
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Study Director: Shirin Pourafshar, PhD Florida State University

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Responsible Party: Bahram Arjmandi, Margaret A. Sitton Professor, Director of Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
ClinicalTrials.gov Identifier: NCT03272074     History of Changes
Other Study ID Numbers: 2015.15638
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia