Effect of Nutritional Products in Subjects With Type 2 Diabetes

Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Standard ONS; Other: Diabetes specific ONS 1; Other: Diabetes specific ONS 2

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Radiant Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard ONS; liquid oral nutritional supplement	Other: Standard ONS; One serving (237 ml) standard oral nutritional beverage
Experimental: Diabetes specific ONS 1; liquid oral nutritional supplement with novel carbohydrate blend	Other: Diabetes specific ONS 1; One serving (237 ml) diabetes oral nutritional beverage
Active Comparator: Diabetes specific ONS 2; liquid oral nutritional supplement with novel carbohydrate blend	Other: Diabetes specific ONS 2; One serving (296 ml) diabetes oral nutritional beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma Glucose Concentration	0 to 240 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Insulin Concentration	0 to 240 minutes

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Owen Kelly, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: BL33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED