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Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes - NCT00831194-21205(Clinical Trial 266009)



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City:  Baltimore
State:  
MD
Zip Code: 21205
Conditions: Obesity - Type 2 Diabetes
Purpose: It is a 6.5 months clinical trial to examine the relationship between self reported stress, an objective biochemical indicator of stress in saliva named salivary alpha amylase and self reported dietary lapse among type 2 diabetic adults who are interested in weight loss.
Study summary: In the study, all participants will be provided with a personalized ADA-based diet plan and a pre-programmed PDA. They will be required to record their mood and activities into the PDA whenever PDA prompts, they break their diet plan and face significant stress. They will also be required to collect their own saliva samples for 6 weeks- 3 times/day; for 2 days/week. In addition to this they will be administered the Trier Social Stress Test once during the study, where they will perform certain stress inducing tasks like delivering a speech and solving maths problems. Salivary samples will be collected before and after these tasks. They will also take various questionnaires during each of the 15 to 16 visits. The completed questionnaires, PDA records and reports of salivary alpha amylase levels will be analyzed to examine the corelation between stress, dietary lapse and weight loss.
Criteria: Inclusion Criteria: - Age 21 to 65 years, seeking weight loss. - Type 2 diabetes diagnosis by American Diabetes Association standard criteria. (Confirmed by physician's note or blood glucose reports in previous year or Prescriptions for medications to control blood glucose dated in participant's name within last year). - BMI > 30 kg/m2. Exclusion Criteria: - Major depression. - Cognitive impairment severe enough to preclude informed consent or valid self report. - Use of medications that significantly affect appetite. - Eating disorder. - Inability or unwillingness to use PDA for 6 months. - Inability or unwillingness to collect saliva samples.
Study is available at: Center for Human Nutrition
Baltimore, MD 21205
United States

Primary Contact:
Lawrence J Cheskin, MD
Email: lcheski1@jhmi.edu
Phone: 410-583-2860
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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