Diet and Exercise Intervention in Type 2 Diabetes (LID)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 30, 2014
Last verified: July 2014

October 14, 2013
July 30, 2014
October 2013
January 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01977560 on ClinicalTrials.gov Archive Site
  • 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.
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
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
Same as current
 
Diet and Exercise Intervention in Type 2 Diabetes
Diet and Exercise Intervention in Type 2 Diabetes

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Behavioral: Optimum Lifestyle Intervention
    Participants will follow a high-protein, low-carbohydrate diet and participate in supervised exercise,
  • Behavioral: Standard Care
    Participants will be given advice on exercise and the American Diabetes Association diet, as if they went to a Diabetes clinic.
  • Standard Care
    This arm will receive standard care for Type 2 diabetes: exercise and diet counseling according to the American Diabetes Association recommendations.
    Intervention: Behavioral: Standard Care
  • 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.
    Intervention: Behavioral: Optimum Lifestyle Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
January 2016   (final data collection date for primary outcome measure)

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.
Both
30 Years to 64 Years
No
Contact: Helene M Parker, BA 314-747-2627 hparker@dom.wustl.edu
Contact: Mihoko Yoshino, MD, PhD 314-362-8228 myoshino@dom.wustl.edu
United States
 
NCT01977560
201302095
Yes
Washington University School of Medicine
Washington University School of Medicine
  • National Dairy Council
  • American Egg Board
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
Washington University School of Medicine
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP