Clinical trial NCT03064347: Targeted Enteral Nutrient Delivery: A Prospective Randomized Study
Official title: Targeted Enteral Nutrient Delivery: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Obesity
Nutrient
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Difference in AUC of GLP-1 on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
Secondary outcomes:
measure: Difference in Peak PYY on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in Peak C-peptide on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in Peak insulin on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in Peak glucose on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in Peak satiety on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in Peak Adverse Events on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in AUC of PYY on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in AUC of C-peptide on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in AUC of insulin on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in AUC of glucose on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in AUC of satiety on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in AUC of adverse symptoms on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
measure: Difference in Peak GLP-1 on meal tolerance tests Enteric Coated vs. Uncoated Nutrient.
timeFrame: From ingestion to 3 hours post ingestion.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Diabetes & Obesity Research Institute (DORI)
state: California
Study officials:
affiliation: University of Southern California, Keck School of Medicine
name: Elizabeth Beale, MD
role: PRINCIPAL_INVESTIGATOR
References: