Diet and Exercise Intervention in Type 2 Diabetes (LID)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
National Dairy Council
American Egg Board
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01977560
First received: October 14, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine the effect of lifestyle intervention on metabolism and blood sugar control in Type 2 Diabetics.


Condition Intervention
Type 2 Diabetes
Behavioral: Optimum Lifestyle Intervention
Behavioral: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diet and Exercise Intervention in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Glycemic Control [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    This aim will be evaluated by assessment of: i) fasting plasma glucose; ii) glycated hemoglobin (HbA1c); iii) use of diabetes medications and iv) resolution of Type 2 diabetes, defined as a fasting plasma glucose <126 mg/dL, 2-hr oral glucose tolerance test plasma glucose <200 mg/dL, HbA1c <6.5% and discontinuation of all diabetes medications.


Secondary Outcome Measures:
  • Glucose metabolism [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Liver and skeletal muscle insulin sensitivity, β-cell function, and cellular factors in skeletal muscle and adipose tissue that regulate glucose metabolism

  • Neuronal Function [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    This aim will be evaluated by assessing by administration of cognitive testing and brain MRI.

  • Acceptability and Feasibility of Intervention [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    This aim will be evaluated by using semi-structured interviews to assess accessibility and feasibility In addition, participants' time spent on intervention activities and delivery will be determined.


Other Outcome Measures:
  • Cardiovascular risk factors [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Plasma lipid profile; markers of inflammation, body fat distribution (visceral adipose tissue (VAT) intrahepatic triglyceride (IHTG) content and intramyocardial TG content), and cardiovascular structure and function


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard Care
This arm will receive standard care for Type 2 diabetes: exercise and diet counseling according to the American Diabetes Association recommendations.
Behavioral: Standard Care
Participants will be given advice on exercise and the American Diabetes Association diet, as if they went to a Diabetes clinic.
Experimental: Optimum Lifestyle intervention
This arm will be participate in weekly visits with a dietitian and 4 weekly supervised exercise sessions. They will be advised to follow a high-protein, low-carbohydrate diet.
Behavioral: Optimum Lifestyle Intervention
Participants will follow a high-protein, low-carbohydrate diet and participate in supervised exercise,

  Eligibility

Ages Eligible for Study:   30 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 30-64 yrs old
  2. BMI 28.0-42.0 kg/m2
  3. Diagnosis of type 2 diabetes based on HbA1C>6.5% or results of an oral glucose tolerance test or current use of anti-diabetic medications
  4. Reported duration of type 2 diabetes <8years
  5. HbA1C ≤8.5 %.
  6. Work at Washington University in St. Louis, Barnes Jewish Hospital or St. Louis Childrens Hospital.

Exclusion Criteria:

  1. Diabetes therapy with long-acting Glucagon-like peptide-1 agonist (i.e. Bydureon), thiazolidinedione, or insulin
  2. Any change in diabetes medication in previous 3 months
  3. Unstable weight (>2% change during the last 2 months before entering the study)
  4. History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or New York Heart Association class III heart failure (patients with marked limitation of activity and who are comfortable only at rest) or IV heart failure (patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity).
  5. Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
  6. Creatinine >1.5 mg/dL
  7. Microalbuminuria; spot urine albumin:creatinine ratio >30 (30 μg albumin/mg creatinine)
  8. Coagulation disorders
  9. Anemia (Hemoglobin <10.0 g/dL)
  10. Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
  11. Uncontrolled proliferative diabetic retinopathy
  12. Severe peripheral neuropathy diagnosed by monofilament testing
  13. Severe organ dysfunction
  14. Pregnant or breastfeeding
  15. Participating in regular exercise (>1 h of structured exercise/week)
  16. Joint replacement within the last year
  17. Smokes tobacco
  18. Severe lactose intolerance
  19. Take any medication that might interfere with interpretation of the metabolic studies
  20. Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977560

Contacts
Contact: Helene M Parker, BA 314-747-2627 hparker@dom.wustl.edu
Contact: Mihoko Yoshino, MD, PhD 314-362-8228 myoshino@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Dairy Council
American Egg Board
Investigators
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01977560     History of Changes
Other Study ID Numbers: 201302095
Study First Received: October 14, 2013
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Type 2 diabetes
exercise
high protein

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

ClinicalTrials.gov processed this record on July 22, 2014