NCT02612675

Brief Summary

This will be a randomized, cross-over study of two oral nutrition supplements in individuals with Type 2 Diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

1 month

First QC Date

November 20, 2015

Last Update Submit

November 20, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Area under the blood glucose curve (AUC 0-240)

    Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Study Arms (2)

Standard ONS

ACTIVE COMPARATOR

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption

Other: ONS

Low Carbohydrate ONS

EXPERIMENTAL

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption

Other: ONS

Interventions

ONSOTHER
Low Carbohydrate ONSStandard ONS

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-75 yrs
  • Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg

You may not qualify if:

  • Allergy to milk protein or any other component of the formula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes & Glandular Disease Clinic, PA

San Antonio, Texas, 78229-4801, United States

Location

Related Publications (1)

  • Huhmann MB, Smith KN, Schwartz SL, Haller SK, Irvin S, Cohen SS. Plasma glucose and insulin response to two oral nutrition supplements in adults with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2016 Aug 31;4(1):e000240. doi: 10.1136/bmjdrc-2016-000240. eCollection 2016.

    PMID: 27648290DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sherwyn Schwartz, MD

    Diabetes & Glandular Disease Clinic, PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 24, 2015

Study Start

January 1, 2013

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

US(1)