|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Plant-Based Dietary Intervention in Type 2 Diabetes | ||||
| Official Title † | Plant-Based Dietary Intervention in Type 2 Diabetes | ||||
| Brief Summary | The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up. |
||||
| Detailed Description | Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. We therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance. |
||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Hemoglobin A1c [ Time Frame: 22 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Body weight [ Time Frame: 22 weeks ] [ Designated as safety issue: No ] Plasma lipid concentrations [ Time Frame: 22 weeks ] [ Designated as safety issue: No ] Urinary albumin [ Time Frame: 22 weeks ] [ Designated as safety issue: No ] Dietary Acceptability [ Time Frame: 22 weeks ] [ Designated as safety issue: No ] |
||||
| Condition † | Diabetes Mellitus, Type 2 | ||||
| Intervention † | Behavioral: Low-fat, low-Glycemic Index, vegan diet | ||||
| MEDLINE PMIDs | 16873779, 10446033, 16164885, 15325679, 15286527, 12936955 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 99 | ||||
| Start Date † | September 2003 | ||||
| Completion Date | July 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00276939 | ||||
| Organization ID | PCRM GWU DM Study | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | The Washington Center for Clinical Research | ||||
| Collaborators †† | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Diabetes Action Research and Education Foundation George Washington University University of Toronto |
||||
| Investigators † |
|
||||
| Information Provided By | The Washington Center for Clinical Research | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | January 11, 2006 | ||||
| Last Updated Date | July 29, 2008 | ||||