NCT04215328

Brief Summary

The overall objective is to develop therapy for obesity and diabetes that is as effective as gastric bypass surgery but without the cost and safety concerns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable diabetes-mellitus-type-2

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

November 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

4.3 years

First QC Date

December 26, 2019

Last Update Submit

January 2, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

ObesityDiabetes Mellitus, Type 2Nutrient

Outcome Measures

Primary Outcomes (1)

  • Weight change between groups

    Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group

    Day 0 to Day 14

Secondary Outcomes (6)

  • Caloric intake within and between groups

    Day 0 to Day 14

  • Weight change within group

    Day 0 to Day 14

  • Change in waist and hip measurements

    Day 0 to Day 14

  • Change in systolic and diastolic blood pressure

    Day 0 to Day 14

  • Change in heart rate

    Day 0 to Day 14

  • +1 more secondary outcomes

Study Arms (2)

Mixed-Meal

EXPERIMENTAL

Ensure Nutrition Shake

Dietary Supplement: Mixed-Meal

Electrolyte Solution

PLACEBO COMPARATOR

Pedialyte Solution

Dietary Supplement: Electrolyte Solution

Interventions

Mixed-MealDIETARY_SUPPLEMENT

Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses

Also known as: Ensure Nutrition Shake® (Abbott Park, Illinois, U.S.A.)
Mixed-Meal
Electrolyte SolutionDIETARY_SUPPLEMENT

Electrolyte Solution 500mLs by tube daily in 4 doses

Also known as: Unflavored Pedialyte ® (Abbott Park, Illinois, U.S.A.)
Electrolyte Solution

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes on oral antidiabetic medication
  • BMI greater than or equal to 30kg/m2
  • A1C less than 9%

You may not qualify if:

  • Use of any of the following medications: dipeptide-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide) or medication that could alter glucose tolerance (e.g. steroids)
  • Contraindication to tube (e.g. Prior upper gastrointestinal bleed, or history of easy bleeding, altered foregut anatomy due to obstruction or surgery)
  • Known cardiovascular disease other than controlled hypertension.
  • Pregnancy or unwilling to take contraception
  • Active esophagitis
  • Known hiatal hernia
  • Active gastric ulcer and/or duodenal ulcers,
  • Previous restrictive surgery of the gastrointestinal tract
  • Crohn's disease
  • Active cancer
  • History of gastrointestinal hemorrhage
  • Known upper gastrointestinal lesions with potential to bleed
  • Use of NSAIDs or anticoagulants
  • Psychiatric disorders other than mild depression
  • Likely inability to adhere to study protocol including alcohol or drug dependent patients
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roybal Diabetes Management Clinic

Los Angeles, California, 90022, United States

Location

Related Publications (1)

  • Beale EO, Lee W, Lee A, Lee C, Soffer E, Crookes PF, Eagilen K, Chen R, Mack WJ, Tong H. Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial. Nutr Diabetes. 2020 Jun 17;10(1):22. doi: 10.1038/s41387-020-0125-6.

    PMID: 32555148DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Beale, MD

    University of Southern California, Keck School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2019

First Posted

January 2, 2020

Study Start

November 1, 2014

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)