Targeted Enteral Nutrient Delivery: A Prospective Randomized Study

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03064347

Run by

University of Southern California

People needed

19

Starts

2017-02-22

Expected to finish

2018-06-20

Last updated by the study team

2019-06-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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)
• 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.

Where it is running

• USC Diabetes & Obesity Research Institute (DORI) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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