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Anti-inflammatory Effects of the Fiber

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dietary fiber
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring inflammation, insulin resistance, type 2 diabetes, obesity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women 18 to 80 years of age
  2. Non-smoker (last cigarette at least one month ago)
  3. Type 2 diabetes for at least 1 year
  4. Body mass index > 30 kg/m2

Exclusion Criteria:

  1. Participation in any other concurrent clinical trials
  2. Pregnancy or premenopausal women who are trying to be pregnant
  3. Patients who are incompetent to give consent
  4. Patients on non-steroidal anti-inflammatory drugs or steroids
  5. Concurrent disease that could disrupt intestinal epithelium and increase permeability to endotoxin, ie Celiac and Crohns disease.
  6. Hepatic disease (transaminase > 3 times normal)
  7. Renal impairment (serum creatinine > 1.5 mg/dl)
  8. History of drug or alcohol abuse
  9. Use of over the counter or prescribed probiotic supplements.
  10. Recent or current antibiotic use.
  11. Coronary artery disease (CAD): documented by history of myocardial infarction, angioplasty/stent placement, angina, exercise EKG positive for ischemia or angiographic evidence of CAD

Sites / Locations

  • ECMC Ambulatory Center, 3rd FloorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

high fat high calorie

high fat high calorie plus fiber

Arm Description

Subjects in this arm will receive high fat high calorie meal

Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation

Outcomes

Primary Outcome Measures

change in plasma reactive oxygen species generated by mononuclear cells from baseline
mononuclear cells will be isolated by Ficoll-Hypaque method. reactive oxygen species will be measured by chemiluminescence as an index of NADPH oxidase activation
change in plasma dipeptidyl peptidase IV enzyme level from baseline
It will be measured by enzyme-linked immunosorbent assays

Secondary Outcome Measures

change in plasma Tumor Necrosis Factor level alpha from baseline
RNA isolation and real time RT-PCR will be performed to measure expression of tumor necrosis factor alpha
change in plasma Toll Like Receptor-4 level from baseline
Toll Like Receptor-4 will be measured by Western Blots
change in plasma Toll Like Receptor-2 level from baseline
Toll Like Receptor-2 will be measured by Western Blots
change in plasma level of Suppressor of Cytokine Signaling 3 from baseline
Suppressor of Cytokine Signaling 3 will be measured by Western Blots
change in plasma Protein Tyrosine Phosphatase-1B from baseline
RNA isolation and real time RT-PCR will be performed to measure expression of Protein Tyrosine Phosphatase-1B
change in plasma lipopolysaccharides level from baseline
Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD)
change in plasma insulin level from baseline
Insulin level will be measured by enzyme-linked immunosorbent assays
change in plasma glucose level from baseline
Glucose level will be measured by YSI 2300 STAT Plus glucose analyzer (Yellow Springs, Ohio)
change in plasma incretin level from baseline
Incretin level will be measured by enzyme-linked immunosorbent assays

Full Information

First Posted
August 8, 2016
Last Updated
November 2, 2017
Sponsor
University at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT02868788
Brief Title
Anti-inflammatory Effects of the Fiber
Official Title
Anti-inflammatory and ROS Suppressive Effects of the Fiber Supplementation to a High Fat High Calorie Meal in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 14, 2016 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will help elucidate the mechanism underlying the cardioprotective and anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and oxidative stress markers, based on a contemporary understanding of this process. In addition, there have been very few studies that explored the immediate change in oxidative stress and incretin secretion after fiber intake. In this study, the investigators will be able assess the short term metabolic impact of dietary fiber at great details. The result will contribute to dietary recommendation or designing of fiber supplementation for prevention/treatment of diabetes, obesity and cardiovascular disease.
Detailed Description
Baseline labs include complete blood count (CBC), comprehensive metabolic panel (CMP), Hemoglobin A1C, and lipid profile. All labs will be drawn in the fasting state Visit 1: Subjects will arrive after having fasted overnight (10 hours) at 7 to 7:30 am. An indwelling intravenous cannula will be placed in the anterior cubital vein for blood draws. A blood sample of the research labs and a urine sample will be collected. Blood pressure, heart rate and weight will be measured. Subjects will consume either a High Fat High Calorie (HFHC) meal or HFHC meal plus fiber (FiberOne Original cereal) according to randomization. Fiber will be consumed before and after the HFHC meal (28 grams in total, 14 grams before and after the meal). HFHC meal includes an egg muffin sandwich, a sausage muffin sandwich and two hash browns which contain 88g carbohydrate, 51 g fat (33% saturated) and 34 g protein. 35 ml of blood will be obtained at 1h , 2h, 3h and 5 h and 5 ml at 15 min,30 min,45 min,75 min and 90 min. A total of 165 ml (11 tablespoon) blood will be collected. . Visit 2: Subjects will return 1 week later after overnight fasting (10 hours) at 7 to 7:30 am. Blood pressure, heart rate and weight will be measured. Baseline blood and urine samples will be collected again and subjects will be crossed over to receive the second meal (HFHC only or HFHC with fiber). Visit details are similar to visit 1. After this, the subject will be discharged from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
inflammation, insulin resistance, type 2 diabetes, obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high fat high calorie
Arm Type
Other
Arm Description
Subjects in this arm will receive high fat high calorie meal
Arm Title
high fat high calorie plus fiber
Arm Type
Experimental
Arm Description
Subjects in this arm will receive high fat high calorie meal plus dietary fiber supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary fiber
Other Intervention Name(s)
Fiber One
Primary Outcome Measure Information:
Title
change in plasma reactive oxygen species generated by mononuclear cells from baseline
Description
mononuclear cells will be isolated by Ficoll-Hypaque method. reactive oxygen species will be measured by chemiluminescence as an index of NADPH oxidase activation
Time Frame
1 week
Title
change in plasma dipeptidyl peptidase IV enzyme level from baseline
Description
It will be measured by enzyme-linked immunosorbent assays
Time Frame
1 week
Secondary Outcome Measure Information:
Title
change in plasma Tumor Necrosis Factor level alpha from baseline
Description
RNA isolation and real time RT-PCR will be performed to measure expression of tumor necrosis factor alpha
Time Frame
1 week
Title
change in plasma Toll Like Receptor-4 level from baseline
Description
Toll Like Receptor-4 will be measured by Western Blots
Time Frame
1 week
Title
change in plasma Toll Like Receptor-2 level from baseline
Description
Toll Like Receptor-2 will be measured by Western Blots
Time Frame
1 week
Title
change in plasma level of Suppressor of Cytokine Signaling 3 from baseline
Description
Suppressor of Cytokine Signaling 3 will be measured by Western Blots
Time Frame
1 week
Title
change in plasma Protein Tyrosine Phosphatase-1B from baseline
Description
RNA isolation and real time RT-PCR will be performed to measure expression of Protein Tyrosine Phosphatase-1B
Time Frame
1 week
Title
change in plasma lipopolysaccharides level from baseline
Description
Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD)
Time Frame
1 week
Title
change in plasma insulin level from baseline
Description
Insulin level will be measured by enzyme-linked immunosorbent assays
Time Frame
1 week
Title
change in plasma glucose level from baseline
Description
Glucose level will be measured by YSI 2300 STAT Plus glucose analyzer (Yellow Springs, Ohio)
Time Frame
1 week
Title
change in plasma incretin level from baseline
Description
Incretin level will be measured by enzyme-linked immunosorbent assays
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 to 80 years of age Non-smoker (last cigarette at least one month ago) Type 2 diabetes for at least 1 year Body mass index > 30 kg/m2 Exclusion Criteria: Participation in any other concurrent clinical trials Pregnancy or premenopausal women who are trying to be pregnant Patients who are incompetent to give consent Patients on non-steroidal anti-inflammatory drugs or steroids Concurrent disease that could disrupt intestinal epithelium and increase permeability to endotoxin, ie Celiac and Crohns disease. Hepatic disease (transaminase > 3 times normal) Renal impairment (serum creatinine > 1.5 mg/dl) History of drug or alcohol abuse Use of over the counter or prescribed probiotic supplements. Recent or current antibiotic use. Coronary artery disease (CAD): documented by history of myocardial infarction, angioplasty/stent placement, angina, exercise EKG positive for ischemia or angiographic evidence of CAD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paresh Dandona, MD
Phone
716-898-1940
Email
pdandona@kaleidahealth.org
Facility Information:
Facility Name
ECMC Ambulatory Center, 3rd Floor
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paresh Dandona, MD
Phone
716-898-1940
Email
pdandona@kaleidahealth.org
First Name & Middle Initial & Last Name & Degree
Jeanne Hejna, LPN
Phone
716-898-1944
Email
jeannehe@buffalo.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Anti-inflammatory Effects of the Fiber

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