Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Targeted Enteral Nutrient Delivery: A Prospective Randomized Study (TEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03064347
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Beale, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: Sucrose plus Whole Milk Powder in Enteric Coating Dietary Supplement: Non coated Sucrose plus Whole Milk Dietary Supplement: Sucrose in Enteric Coating Dietary Supplement: Sucrose with Separate Enteric Coating Materials Dietary Supplement: Whey Protein in Enteric Coating Dietary Supplement: Whey Protein with Separate Enteric Coating Materials Dietary Supplement: Pea Protein in Enteric Coating Dietary Supplement: Pea Protein with Separate Enteric Coating Materials Not Applicable

Detailed Description:
Direct delivery of nutrient to the upper intestine by enteral feeding tube can increase circulating levels of some glucose and appetite regulating hormones when compared to usual oral ingestion. Such an enhancement could be of value in the management of type 2 diabetes and obesity. In this study enteric-coated nutrients will be ingested to allow for direct delivery of nutrient to the upper intestine. Levels of select hormones and glucose, and measures of satiety and adverse effects will be compared following the ingestion of uncoated and enteric coated nutrient.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Targeted Enteral Nutrient Delivery: A Prospective Randomized Study
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

Arm Intervention/treatment
Active Comparator: Coated Sucrose plus Whole Milk
200kcal sucrose plus whole milk powder in enteric coating as single dose
Dietary Supplement: Sucrose plus Whole Milk Powder in Enteric Coating
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.

Placebo Comparator: Non Coated Sucrose plus Whole Milk
200kcal sucrose plus whole milk powder with separate enteric coating materials as single dose
Dietary Supplement: Non coated Sucrose plus Whole Milk
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.

Active Comparator: Enteric Coated Sucrose
200kcal sucrose in enteric coating as single dose
Dietary Supplement: Sucrose in Enteric Coating
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.

Placebo Comparator: Non-Enteric Coated Sucrose
200kcal sucrose with separate enteric coating materials as single dose
Dietary Supplement: Sucrose with Separate Enteric Coating Materials
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.

Active Comparator: Enteric Coated Whey Protein
200kcal whey protein in enteric coating as single dose
Dietary Supplement: Whey Protein in Enteric Coating
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.

Placebo Comparator: Non-Enteric Coated Whey Protein
200kcal whey protein with separate enteric coating materials as single dose
Dietary Supplement: Whey Protein with Separate Enteric Coating Materials
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.

Active Comparator: Enteric Coated Pea Protein
200kcal pea protein in enteric coating as single dose
Dietary Supplement: Pea Protein in Enteric Coating
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.

Placebo Comparator: Non-Enteric Coated Pea Protein
200kcal pea protein with separate enteric coating materials as single dose
Dietary Supplement: Pea Protein with Separate Enteric Coating Materials
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.




Primary Outcome Measures :
  1. Difference in AUC of GLP-1 on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Integrated Area under the curve (AUC) levels of blood GLP-1 on meal tolerance tests.


Secondary Outcome Measures :
  1. Difference in Peak PYY on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Highest level of blood PYY on 3 hour meal tolerance test

  2. Difference in Peak C-peptide on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Highest level of blood C-peptide on 3 hour meal tolerance test

  3. Difference in Peak insulin on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Highest level of blood insulin on 3 hour meal tolerance test

  4. Difference in Peak glucose on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Highest level of blood glucose on 3 hour meal tolerance test

  5. Difference in Peak satiety on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Highest level of satiety on 3 hour meal tolerance test measured on a 15mm visual analog scale

  6. Difference in Peak Adverse Events on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Highest level of adverse symptoms on 3 hour meal tolerance test measured on a 15mm visual analog scale

  7. Difference in AUC of PYY on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Integrated Area under the curve (AUC) levels of blood PYY on meal tolerance tests.

  8. Difference in AUC of C-peptide on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Integrated Area under the curve (AUC) levels of blood C-peptide on meal tolerance tests.

  9. Difference in AUC of insulin on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Integrated Area under the curve (AUC) levels of blood insulin on meal tolerance tests.

  10. Difference in AUC of glucose on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Integrated Area under the curve (AUC) levels of blood glucose on meal tolerance tests.

  11. Difference in AUC of satiety on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Integrated Area under the curve (AUC) levels of satiety on meal tolerance tests of adverse symptoms on 3 hour meal tolerance test measured on a 15mm visual analog scale

  12. Difference in AUC of adverse symptoms on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Integrated Area under the curve (AUC) levels of adverse symptoms on meal tolerance tests of adverse symptoms on 3 hour meal tolerance test measured on a 15mm visual analog scale

  13. Difference in Peak GLP-1 on meal tolerance tests Enteric Coated vs. Uncoated Nutrient. [ Time Frame: From ingestion to 3 hours post ingestion. ]
    Highest level of blood GLP-1 on 3 hour meal tolerance test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 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

Exclusion Criteria:

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)
  • Simultaneous participation in any other clinical trial of an investigational drug
  • The receipt of any investigational product within four weeks prior to screening for this trial Herbal supplements or over-the-counter medications
  • Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening into this trial Other
  • Milk allergy
  • Lactose intolerance Language barrier, mental incapacity, unwillingness or inability to understand and be able to complete the study Females of childbearing potential
  • Pregnant breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by US: abstinence and the following methods: diaphragm with spermacide, condom with spermacide (by male partner), intrauterine device, sponge, spermacide, Norplant®, Depo-Provera® or oral contraceptives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064347


Locations
Layout table for location information
United States, California
USC Diabetes & Obesity Research Institute (DORI)
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Beale, MD University of Southern California, Keck School of Medicine
Layout table for additonal information
Responsible Party: Elizabeth Beale, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03064347    
Other Study ID Numbers: TEND HS-16-00339
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Beale, University of Southern California:
Diabetes Mellitus, Type 2
Obesity
Nutrient
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases