View Clinical Trial (Medical Research Study)
A Comparison of Glycemic Stability and Variability During Consumption of Usual Diet or a Commercially Available Portion-controlled Diet Among Patients With Type 2 Diabetes
| City: |
|
Philadelphia |
| State: |
|
Pennsylvania |
| Zip Code: |
|
|
| Conditions: |
|
Type 2 Diabetes - Obesity |
| Purpose: |
|
This investigation will examine the effects of consuming a structured, portion-controlled,
low-glycemic index diet (commercially available as the Nutrisystem-D program) on several
indicators of glycemic stability and variability among participants with type 2 diabetes.
Results on the portion-controlled diet will be compared with those on participants' usual
diets in a randomized cross-over trial. The investigators expect that participants will
exhibit greater glycemic stability (e.g., more time in euglycemic range) and less glycemic
variability (e.g., smaller mean amplitude of glycemic excursions) while consuming the
Nutrisystem D program, as compared with their usual diet.
|
| Study Summary: |
|
This study will investigate glycemic stability and variability in response to two diets:
usual diet and a commercially available portion-controlled diet. The commercially available
diet will be the Nutrisystem-D program, which consists of pre-packaged meals and snacks that
are supplemented with grocery items, including fruits, vegetables, and dairy items. This
trial will be a randomized cross-over trial of 15 patients with type 2 diabetes (weight
stable for at least 3 months prior and medication stable throughout the trial).
Participants will consume each diet for a 2-week period. During each diet period,
participants will wear a blinded (i.e., providing no feedback) continuous glucose monitoring
(CGM) device to assess glycemic stability and variability, and will be instructed to keep a
detailed record of food and beverage intake and physical activity. The two diet/assessment
periods will be separated by a 1-week washout period during which no dietary instruction
will be given and no outcomes will be measured. Laboratory values (HbA1c, glucose, insulin,
lipid panel) and physical measures (height, weight, waist circumference, blood pressure)
will be assessed at the baseline for descriptive purposes.
Primary Hypothesis: A significantly greater percentage of CGM readings will fall in the
euglycemic range (71-180 mg/dl) during consumption of the Nutrisystem-D program, as compared
with Usual Diet.
Secondary Hypothesis: Participants will have significantly smaller areas under the curve,
mean amplitude of glycemic excurisions, mean, standard deviation, and interquartile range
of glucose values, and a smaller of percentage of values in the hypo- (</= 70 mg/dl) and
hyperglycemic (>180 mg/dl) ranges during consumption of the Nutrisystem-D program, as
compared with Usual Diet.
|
| Criteria: |
|
Inclusion Criteria:
- Diagnosis of type 2 diabetes
- Body mass index (BMI) of 27 to 45 kg/m2
- Capacity to provide written informed consent
- Willing and committed to return for all clinic visits and complete all study-related
procedures
- Men and women of all racial and ethnic groups are eligible for participation
Exclusion Criteria:
- Use of hypoglycemic medications (e.g., sulfonylureas, insulin)
- Food allergies or intolerances that would render adherence to the test diets
unpleasant or unsafe
- Use of anticoagulant medications (e.g., warfarin)
- Pregnant or lactating
- More than a 5% weight gain or loss within the last 3 months
- More than one alcoholic drink per day
- Binge eating disorder
- Regular use of acetaminophen
|
| NCT ID: |
|
NCT01443143 |
| Primary Contact: |
|
Principal Investigator
Thomas A Wadden, Ph.D.
University of Pennsylvania
L
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Philadelphia, Pennsylvania
United States
Dana Tioxon
Phone: 215-573-7520
Email: tida@mail.med.upenn.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 20, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|