Diet and Exercise Intervention in Type 2 Diabetes (LID)
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|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.
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 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|