Targeted Enteral Nutrient Delivery: A Prospective Randomized Study
TEND
1 other identifier
interventional
19
1 country
1
Brief Summary
This study will evaluate whether enteric-coated nutrients increase some glucose and regulating hormone levels, glucose tolerance and satiety in overweight and obese individuals with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2017
CompletedStudy Start
First participant enrolled
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2018
CompletedJune 18, 2019
June 1, 2019
1.3 years
February 17, 2017
June 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in AUC of GLP-1 on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
Integrated Area under the curve (AUC) levels of blood GLP-1 on meal tolerance tests.
From ingestion to 3 hours post ingestion.
Secondary Outcomes (13)
Difference in Peak PYY on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
From ingestion to 3 hours post ingestion.
Difference in Peak C-peptide on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
From ingestion to 3 hours post ingestion.
Difference in Peak insulin on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
From ingestion to 3 hours post ingestion.
Difference in Peak glucose on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
From ingestion to 3 hours post ingestion.
Difference in Peak satiety on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
From ingestion to 3 hours post ingestion.
- +8 more secondary outcomes
Study Arms (8)
Coated Sucrose plus Whole Milk
ACTIVE COMPARATOR200kcal sucrose plus whole milk powder in enteric coating as single dose
Non Coated Sucrose plus Whole Milk
PLACEBO COMPARATOR200kcal sucrose plus whole milk powder with separate enteric coating materials as single dose
Enteric Coated Sucrose
ACTIVE COMPARATOR200kcal sucrose in enteric coating as single dose
Non-Enteric Coated Sucrose
PLACEBO COMPARATOR200kcal sucrose with separate enteric coating materials as single dose
Enteric Coated Whey Protein
ACTIVE COMPARATOR200kcal whey protein in enteric coating as single dose
Non-Enteric Coated Whey Protein
PLACEBO COMPARATOR200kcal whey protein with separate enteric coating materials as single dose
Enteric Coated Pea Protein
ACTIVE COMPARATOR200kcal pea protein in enteric coating as single dose
Non-Enteric Coated Pea Protein
PLACEBO COMPARATOR200kcal pea protein with separate enteric coating materials as single dose
Interventions
Single dose enteric coated sucrose plus whole milk powder will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Single dose sucrose plus whole milk powder with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Single dose enteric coated sucrose will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Single dose sucrose with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Single dose enteric coated whey protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Single dose whey protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Single dose enteric coated pea protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Single dose pea protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
Eligibility Criteria
You may qualify if:
- years of age
- BMI \>27kg/m2
- Type 2 diabetes with known duration of \<10years
- On metformin, sulfonylureas, thiazolidinedione or SGLT2 inhibitor or lifestyle management alone or in combination only for management of type 2 diabetes
You may not qualify if:
- Conditions
- Known foregut pathology or prior foregut surgery.
- Previous surgical treatment for obesity (excluding liposuction if performed \> one year before trial entry)
- Known cardiovascular disease other than controlled hypertension
- Known proliferative retinopathy or maculopathy requiring acute treatment, as judged by the Investigator
- Known untreated or uncontrolled hypothyroidism/hyperthyroidism
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome)
- Cancer (past or present except basal cell skin cancer or squamous cell skin cancer), which in the Investigator's opinion could interfere with the results of the trial
- Use of insulin, DPP4 inhibitors or GLP-1 analogs in the previous 1 month
- Treatment with any antidiabetic agent(s) other than metformin, sulphonylurea thiazolidinedione or SGLT-2 inhibitors in the 1 month prior to screening
- Use of any drug (except for metformin, sulphonylurea or thiazolidinedione or SGLT-2 inhibitors), which in the Investigator's opinion could interfere with glucose level (e.g. systemic corticosteroids)
- Receipt of any other anti-diabetic investigational drug within 1 month prior to screening for this trial, or receipt of any investigational drugs not affecting diabetes within 1 month prior to screening for this trial
- Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapin, paroxetine, phenelzine, clorpromazine, olanzapine,valproic acid and its derivatives, and lithium) thioridazine, clozapine,
- Currently using or have used within three months prior to screening for this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine (either by prescription or as part of a clinical trial)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USC Diabetes & Obesity Research Institute (DORI)
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Beale, MD
University of Southern California, Keck School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 17, 2017
First Posted
February 27, 2017
Study Start
February 22, 2017
Primary Completion
June 20, 2018
Study Completion
June 20, 2018
Last Updated
June 18, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share