Diet and Exercise Intervention in Type 2 Diabetes (LID)
|ClinicalTrials.gov Identifier: NCT01977560|
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : April 26, 2017
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Neuronal Function [ Time Frame: 8 months ]This aim will be evaluated by assessing by administration of cognitive testing and brain MRI.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977560
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Samuel Klein, MD||Washington University School of Medicine|