Diet and Exercise Intervention in Type 2 Diabetes (LID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01977560
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : April 26, 2017
National Dairy Council
American Egg Board
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Optimum Lifestyle Intervention Behavioral: Standard Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diet and Exercise Intervention in Type 2 Diabetes
Actual Study Start Date : October 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Glycemic Control [ Time Frame: 8 months ]
    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 :
  1. Glucose metabolism [ Time Frame: 8 months ]
    Liver and skeletal muscle insulin sensitivity, β-cell function, and cellular factors in skeletal muscle and adipose tissue that regulate glucose metabolism.

  2. Neuronal Function [ Time Frame: 8 months ]
    This aim will be evaluated by assessing by administration of cognitive testing and brain MRI.

  3. Acceptability and Feasibility of Intervention [ Time Frame: 8 months ]
    This aim will be evaluated by using semi-structured interviews to assess accessibility and feasibility. In addition, participants' time spent on intervention activities will be determined.

Other Outcome Measures:
  1. Cardiovascular risk factors [ Time Frame: 8 months ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   25 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 25-68 yrs old
  2. BMI 27.0-50.0 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. HbA1C ≤9.5 %.
  5. Work at Washington University in St. Louis, Barnes Jewish Hospital, St. Louis Children's Hospital, Shriners, St. Louis College of Pharmacy, Central Institute for the Deaf, Rehabilitation Institute of St. Louis, and/or any institutions affiliated with these.

Exclusion Criteria:

  1. Any change in diabetes medication in previous 3 months
  2. Unstable weight (>2% change during the last 2 months before entering the study)
  3. 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).
  4. Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
  5. Creatinine >1.5 mg/dL
  6. Microalbuminuria; spot urine albumin:creatinine ratio >50 (50 μg albumin/mg creatinine)
  7. Coagulation disorders
  8. Anemia (Hemoglobin <10.0 g/dL)
  9. Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
  10. Uncontrolled proliferative diabetic retinopathy
  11. Severe peripheral neuropathy diagnosed by monofilament testing
  12. Severe organ dysfunction
  13. Pregnant or breastfeeding
  14. Participating in regular exercise (>1 h of structured exercise/week)
  15. Joint replacement within the last year
  16. Smokes tobacco
  17. Severe lactose intolerance
  18. Take any medication that might interfere with interpretation of the metabolic studies
  19. 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.

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 identifier (NCT number): NCT01977560

United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Dairy Council
American Egg Board
Principal Investigator: Samuel Klein, MD Washington University School of Medicine

Responsible Party: Washington University School of Medicine Identifier: NCT01977560     History of Changes
Other Study ID Numbers: 201302095
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

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

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

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