Clinical trial NCT02923960: Effect of Nutritional Products in Subjects With Type 2 Diabetes
Official title: Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomized, double blinded, multi treatment, crossover study intended to compare the glycemic and insulinemic response after consuming liquid nutritional products in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subject has type 2 diabetes
* Subject is a male or a nonpregnant, nonlactating female, at least 6 weeks postpartum prior to screening visit
* Subject's BMI is \> 18.5 kg/m2 and \< 35 kg/m2
* If on a chronic medication such as antihypertensive, lipid lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit
* Subject states willingness to follow protocol as described, including consumption of study product per protocol and completing any required study forms
* Participant must refrain from taking medications/dietary supplements/herbals or substances that could modulate glucose metabolism (other than oral hypoglycemic medications), or considered anabolic, or reduce weight (fat mass)

Exclusion Criteria:

* Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Subject is known to be allergic or intolerant to any ingredient found in the study products
* Subject is participating in another study that has not been approved as a concomitant study
* Subject uses exogenous insulin for glucose control, or subject states that they have been diagnosed as having Type 1 diabetes
* Subject states they have a history of diabetic ketoacidosis
* Subject is currently on a low carbohydrate or very low carbohydrate diet
* Subject states that he/she has a current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit
* Subject states that he/she has an active malignancy
* Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure
* Subject states that he/she has end stage organ failure or is status post organ transplant
* Subject is diagnosed with chronic kidney disease, or a history of kidney issues
* Subject states they have impaired liver function, or have a history of liver disease
* Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other severe forms of gastrointestinal disease such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, or ischemic colitis, or any other related condition that may cause unnecessary subject discomfort
* Subject states they have a chronic, contagious, infectious disease
* Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that are designed to affect blood glucose.
* Subject states that he/she has clotting or bleeding disorders
* If selected for continuous blood glucose monitoring, subject has skin lesions, hyperhidrosis, eczema, psoriasis, scarring, redness, infection or edema at the flash constant glucose monitoring application site(s) that could interfere with device placement or the accuracy of interstitial glucose measurements.
* If selected for continuous blood glucose monitoring, subject has an X-ray, MRI or CT appointment scheduled during the period of study participation, or another procedure that would require removal of the flash constant glucose monitoring sensor.
* Subjects on sulfonylureas, meglitinides, and α-glucosidase inhibitors, insulin, or subject on more than two oral hypoglycemic medications excluding aforementioned.
* Subjects on oral hypoglycemic medications that has changed in last 2 months.
* Subject's HbA1c, per point of care device is \> 8%

Primary outcomes:
measure: Plasma Glucose Concentration
timeFrame: 0 to 240 minutes
Secondary outcomes:
measure: Serum Insulin Concentration
timeFrame: 0 to 240 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Owen Kelly, PhD
role: STUDY_CHAIR
References: