Effect of Nutritional Products in Subjects With Type 2 Diabetes

NCT02923960 | Completed

• 1 other identifier: BL33
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Plasma Glucose Concentration

  0 to 240 minutes

Secondary Outcomes (1)

• Serum Insulin Concentration

  0 to 240 minutes

Study Arms (3)

Standard ONS

ACTIVE COMPARATOR

liquid oral nutritional supplement

Other: Standard ONS

Diabetes specific ONS 1

EXPERIMENTAL

liquid oral nutritional supplement with novel carbohydrate blend

Other: Diabetes specific ONS 1

Diabetes specific ONS 2

ACTIVE COMPARATOR

liquid oral nutritional supplement with novel carbohydrate blend

Other: Diabetes specific ONS 2

Interventions

Standard ONS OTHER

One serving (237 ml) standard oral nutritional beverage

Standard ONS

Diabetes specific ONS 1 OTHER

One serving (237 ml) diabetes oral nutritional beverage

Diabetes specific ONS 1

Diabetes specific ONS 2 OTHER

One serving (296 ml) diabetes oral nutritional beverage

Diabetes specific ONS 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (2)

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Radiant Research, Inc.

Cincinnati, Ohio, 45236, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Owen Kelly, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

US (2)