An interventional study of Portion-controlled diet and Usual Diet in Type 2 Diabetes and Obesity, sponsored by Nutrisystem, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-09-29.
Sponsored by Nutrisystem, Inc. · Not applicable, Interventional, and Treatment
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 15 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Nutrisystem, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Commercially available diet program (i.e., Nutrisystem D) that includes pre-packaged low-glycemic index portion-controlled entrees and snacks that are supplemented with grocery items in accordance with a structured meal plan.
Other: Portion-controlled diet
Participants' usual consumption of food and beverages.
Dietary Supplement: Usual Diet
During this diet period, participants will consume portion-controlled products from the Nutrisystem-D program for three entrees and one (women) or two (men) snacks per day. These pre-packaged portion-controlled items will be supplemented with grocery additions (fruits, vegetables, and low-fat dairy items) to provide approximately 1300 (women) to 1500 (men) calories per day. The Nutrisystem-D program (i.e., provided foods plus grocery additions) provides approximately 53% of calories from carbohydrate, 22% of calories from fat (6% from saturated fat and 0% from trans fat), and 25% of calories from protein. Women and men on the program consume approximately 1800 and 2000 mg/d, respectively, of sodium, and 31 and 35 g/d, respectively, of fiber.
Also known as: Nutrisystem D
During the usual diet period, participants will not be given any specific instructions about what they should or should not consume. Instead, they will be told to "Eat how you would normally eat if you were not in this study."
Percent of time in euglycemic range
Euglycemia will be defined as a CGM reading in the range of 71-180 mg/dl, inclusive. Percent of time in the euglycemic range each day is automatically generated by the software accompanying the CGM device. Daily values will be averaged over each of the 2-week assessment periods (i.e. during consumption of Usual Diet or Nutrisystem-D program).
Time frame: 2 weeks
AUC
Area under the curve (AUC) for glucose will be calculated (using the trapezoidal method) for each day of monitoring and averaged over each of the 2-week assessment periods.
Time frame: 2 weeks
MAGE
Mean amplitude of glycemic excursions(MAGE) will be calculated (using methods described by Service et al.) for each day of monitoring and averaged over each of the 2-week assessment periods
Time frame: 2 weeks
Mean glucose
Daily values for mean blood glucose will be automatically generated by the software that accompanies the CGM device. These daily values will be averaged over each of the 2-week assessment periods.
Time frame: 2 weeks
SD of glucose values
The daily standard deviation (SD) of blood glucose values will be automatically generated by the software that accompanies the CGM device. These daily values will be averaged over each of the 2-week assessment periods.
Time frame: 2 weeks
IQR of blood glucose
The daily interquartile range(IQR) of blood glucose values will be automatically generated by the software that accompanies the CGM device. These daily values will be averaged over each of the 2-week assessment periods.
Time frame: 2 weeks
Percent of time in hypoglycemic range
Daily values for percent of time in the hypoglycemic range (\< 70 mg/dl) will be automatically generated by the software that accompanies the CGM device. Daily values will be averaged over each of the 2-week assessment periods.
Time frame: 2 weeks
Percent of time in hyperglycemic range
Daily values for percent of time in the hyperlycemic range (\>/= 180 mg/dl) will be automatically generated by the software that accompanies the CGM device. Daily values will be averaged over each of the 2-week assessment periods.
Time frame: 2 weeks
This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nutrisystem, Inc.