Blood Flow Responses to an Oral Glucose Tolerance Test in Type 2 Diabetes (OGTT)
Primary Purpose
Type 2 Diabetes, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring Type II Diabetes, Insulin Resistance, Exercise, Continuous Glucose Monitoring
Eligibility Criteria
Inclusion Criteria:
- Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose >/= 100 mg/dL
- T2D: diagnosed by primary care physician
- BMI: less than 43 kg/m2
- Age: 30-65
Exclusion Criteria:
- Smoking
- Insulin use (other than once daily)
- Underlying conditions that limit ability to exercise safely
- Recent weight gain or loss (> 5% of body weight in 3 months)
- Physically active (> 30 min aerobic exercise, 2 d/wk)
- Recent (< 3 mo) changes in medication use or dose
- Uncontrolled T2D (HbA1c > 10%)
- Advanced retinopathy or neuropathy
- Pregnancy
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
5-10d exercise training
Outcomes
Primary Outcome Measures
The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.
Secondary Outcome Measures
Full Information
NCT ID
NCT00972452
First Posted
September 4, 2009
Last Updated
September 23, 2015
Sponsor
University of Kansas Medical Center
Collaborators
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00972452
Brief Title
Blood Flow Responses to an Oral Glucose Tolerance Test in Type 2 Diabetes
Acronym
OGTT
Official Title
Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators wish to determine whether a short period of exercise training (5-10 days) improves the metabolic and cardiovascular response of people with or at risk of developing type 2 diabetes to eating a meal. In healthy people, blood flow to skeletal muscles increases after eating a meal, and this helps to regulate blood sugar levels by delivering blood sugar to muscles where it can be stored or metabolized. In people with or at risk of type 2 diabetes, blood flow does not increase as much after eating a meal, and this may contribute to elevated blood sugar concentrations observed in these individuals. The investigators wish to determine whether exercise can improve this response.
Detailed Description
Insulin resistance is characterized by decreased sensitivity to the metabolic actions of insulin (glucose disposal) and is a hallmark of obesity and type 2 diabetes (T2D). Insulin resistance is also a prominent component of cardiovascular diseases (CVD), including hypertension, coronary artery disease, and atherosclerosis, which are characterized by endothelial dysfunction. Insulin stimulates two distinct signaling pathways in the endothelium. One produces the vasodilator nitric oxide (NO) through the insulin receptor substrate-1(IRS-1)/endothelial NO synthase (eNOS) pathway while the other stimulates production of endothelin-1 (ET-1), a vasoconstrictor, through the mitogen activated protein kinase (MAPK) pathway. Insulin-mediated glucose disposal is largely dependent upon the vasodilatory effects of insulin; however, in T2D, insulin-stimulated dilation is impaired as a result of an imbalance in NO and ET-1 production, leading to diminished microvascular perfusion and skeletal muscle glucose delivery in response to insulin. The effects of exercise on insulin signaling/action in the endothelium are not fully understood. The purpose of this study is determine the acute effects of aerobic exercise training on cardiometabolic responses to meal ingestion in individuals with insulin resistance or T2D. We will recruit 30 previously sedentary (<60 minutes of planned exercise/week) men and women with insulin resistance (pre-diabetes) or T2D for participation in this study. Participants will undergo a screening procedure, including telephone screening and physical examination, as well as determination of body composition and fitness. Participants will be asked to complete 5-10 days of supervised exercise training and will undergo testing to assess cardiovascular and metabolic responses to an oral glucose tolerance test, including muscle sympathetic nerve activity, blood flow, and circulating glucose and insulin concentrations at baseline and following training. In addition, participants will use continuous glucose monitoring systems for 3 days at baseline and during 3 days of exercise training to assess the effects of acute exercise on postprandial glucose responses to mixed meals in free-living individuals. The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Insulin Resistance
Keywords
Type II Diabetes, Insulin Resistance, Exercise, Continuous Glucose Monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
5-10d exercise training
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
short period of exercise training (5-10 days)
Primary Outcome Measure Information:
Title
The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose >/= 100 mg/dL
T2D: diagnosed by primary care physician
BMI: less than 43 kg/m2
Age: 30-65
Exclusion Criteria:
Smoking
Insulin use (other than once daily)
Underlying conditions that limit ability to exercise safely
Recent weight gain or loss (> 5% of body weight in 3 months)
Physically active (> 30 min aerobic exercise, 2 d/wk)
Recent (< 3 mo) changes in medication use or dose
Uncontrolled T2D (HbA1c > 10%)
Advanced retinopathy or neuropathy
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Thyfault, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22311420
Citation
Mikus CR, Oberlin DJ, Libla J, Boyle LJ, Thyfault JP. Glycaemic control is improved by 7 days of aerobic exercise training in patients with type 2 diabetes. Diabetologia. 2012 May;55(5):1417-23. doi: 10.1007/s00125-012-2490-8. Epub 2012 Feb 4.
Results Reference
derived
PubMed Identifier
21737826
Citation
Mikus CR, Fairfax ST, Libla JL, Boyle LJ, Vianna LC, Oberlin DJ, Uptergrove GM, Deo SH, Kim A, Kanaley JA, Fadel PJ, Thyfault JP. Seven days of aerobic exercise training improves conduit artery blood flow following glucose ingestion in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Sep;111(3):657-64. doi: 10.1152/japplphysiol.00489.2011. Epub 2011 Jul 7.
Results Reference
derived
Learn more about this trial
Blood Flow Responses to an Oral Glucose Tolerance Test in Type 2 Diabetes
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