A Randomized Controlled Trial to Determine the Effects of Diabetes-Specific Formula on Glycemic Control in Individuals With Type 2 Diabetes

Abbott Nutrition1 site in 1 country100 target enrollmentJune 24, 2020

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Abbott Nutrition
Enrollment: 100
Locations: 1
Primary Endpoint: Postprandial blood glucose
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will be conducted using a randomized, controlled, crossover design with three treatments. The purpose of the study is to determine the effects of diabetes-specific formula on glycemic control in individuals with type 2 diabetes.

Detailed Description

All study participants will be asked to attend a test session where their glycemic, insulinemic and satiety response to a test meal will be measured, followed by a seven-day washout period where they will not receive or consume any study meal during this period. This cycle will be repeated until all participants complete three test sessions.

Registry

clinicaltrials.gov

Start Date

June 24, 2020

End Date

October 19, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 21 and ≤ 65 years.
•Participant has type 2 diabetes as evidenced by use of oral antihyperglycemic medication(s), except for DPP-4 inhibitors, with constant dose for at least two months prior to screening and baseline visit. Participant is able to maintain medication number, type and dose throughout the duration of study.
•Participant with a BMI \> 18.5 and ≤ 35.0 kg/m
•Participant is weight stable (has maintained current body weight within 3 kg) for the two months prior to the screening visit.
•Male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study):
•Condoms, sponge, diaphragm or intrauterine device;
•Oral or parenteral contraceptives for 3 months prior to screening visit;
•Vasectomized partner;
•Total abstinence from sexual intercourse.
•If the participant is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, the dosage was constant for at least two months prior to screening and baseline visit. Participant is able to maintain medication number, type and dose throughout the duration of study.

Exclusion Criteria

•Participant has a screening HbA1c level \<7% or ≥ 10%.
•Participant uses exogenous insulin or GLP-1 agonists or DPP-4 inhibitors for glucose control.
•Participant has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis.
•Participant has current infection (requiring medication), inpatient surgery or received systemic corticosteroid treatment (with the exception of inhaled (includes nasal), topical, and ophthalmic steroids) in the last 3 months; or received antibiotics in the last 3 weeks.
•Participant has active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
•Participant has significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure.
•Participant has end stage organ failure (such as end stage renal disease) or was post organ transplant.
•Participant has a history of renal disease or severe gastroparesis.
•Participant has current hepatic disease.
•Participant has had bariatric surgery including gastric balloon; history of gastrointestinal disease (e.g., Crohn's, colitis, celiac) or intestinal surgery that can interfere with consumption or digestion or absorption of study product.