Effect of Nutritional Products in Subjects With Type 2 Diabetes

NCT ID: NCT02923960

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Standard ONS

liquid oral nutritional supplement

Group Type: ACTIVE_COMPARATOR

Standard ONS

Intervention Type: OTHER

One serving (237 ml) standard oral nutritional beverage

Diabetes specific ONS 1

liquid oral nutritional supplement with novel carbohydrate blend

Group Type: EXPERIMENTAL

Diabetes specific ONS 1

Intervention Type: OTHER

One serving (237 ml) diabetes oral nutritional beverage

Diabetes specific ONS 2

liquid oral nutritional supplement with novel carbohydrate blend

Group Type: ACTIVE_COMPARATOR

Diabetes specific ONS 2

Intervention Type: OTHER

One serving (296 ml) diabetes oral nutritional beverage

Interventions

Standard ONS

One serving (237 ml) standard oral nutritional beverage

Intervention Type: OTHER

Diabetes specific ONS 1

One serving (237 ml) diabetes oral nutritional beverage

Intervention Type: OTHER

Diabetes specific ONS 2

One serving (296 ml) diabetes oral nutritional beverage

Intervention Type: OTHER

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Owen Kelly, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

Great Lakes Clinical Trials

Chicago, Illinois, United States

Radiant Research, Inc.

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

BL33

Identifier Type: -

Identifier Source: org_study_id