Status:
COMPLETED
Blood Sugar Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes
Lead Sponsor:
Walter Reed Army Medical Center
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of the study is to determine which of the commonly used meal supplements is the best product for patients with DM. This is important because meal supplements are becoming more popular as m...
Detailed Description
The purpose of the study is to determine which of the commonly used commercial nutritional supplements are preferential for patients with Diabetes Mellitus (DM). We will compare the post-prandial bloo...
Eligibility Criteria
Inclusion
- Ages 18-75 years
- Type-2 diabetes mellitus for over 3 months
- A1c of 7.0 - 10.0% within the past 3 months
- Controlled with diet /exercise and/or on oral anti-diabetic agents which are non-insulin secretatgogues, i.e. Metformin and/or Pioglitazone
- Able to give informed consent
- Expected to be in the DC metropolitan for the duration of the study
- Fasting blood glucose between 70 and 250 mg/dl
Exclusion
- Patients with type 2 diabetes mellitus treated with insulin secretagogues (sulfonylurea and non-sulfonylurea), pramlintide (Symlin), GLP-1 analogs (Byetta), insulin, or alpha-glycosidase inhibitors
- A1c under 7.0% or over 10.0%
- Fasting blood glucose \< 70 or \> 250 mg/d
- Gastrointestinal disorders affecting digestion and absorption of nutrients such as lactose intolerance, chronic diarrhea, pancreatic insufficiency.
- Clinical history of documented gastroperesis.
- Patients on hemodialysis or peritoneal dialysis
- Pregnancy
- Inability to read and/or speak English
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00822367
Start Date
May 1 2006
End Date
September 1 2007
Last Update
January 14 2009
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