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

University of Southern California

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Whey Protein in Enteric Coating; Dietary Supplement: Sucrose plus Whole Milk Powder in Enteric Coating; Dietary Supplement: Non coated Sucrose plus Whole Milk; Dietary Supplement: Pea Protein in Enteric Coating; Dietary Supplement: Whey Protein with Separate Enteric Coating Materials; Dietary Supplement: Sucrose in Enteric Coating; Dietary Supplement: Pea Protein with Separate Enteric Coating Materials; Dietary Supplement: Sucrose with Separate Enteric Coating Materials

Study type: Interventional

Funder types: Other

Identifiers

NCT03064347

TEND HS-16-00339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 8 patient groups, including a placebo group

Coated Sucrose plus Whole Milk

Active Comparator group

Description:

200kcal sucrose plus whole milk powder in enteric coating as single dose

Treatment:

Dietary Supplement: Sucrose plus Whole Milk Powder in Enteric Coating

Non Coated Sucrose plus Whole Milk

Placebo Comparator group

Description:

200kcal sucrose plus whole milk powder with separate enteric coating materials as single dose

Treatment:

Dietary Supplement: Non coated Sucrose plus Whole Milk

Enteric Coated Sucrose

Active Comparator group

Description:

200kcal sucrose in enteric coating as single dose

Treatment:

Dietary Supplement: Sucrose in Enteric Coating

Non-Enteric Coated Sucrose

Placebo Comparator group

Description:

200kcal sucrose with separate enteric coating materials as single dose

Treatment:

Dietary Supplement: Sucrose with Separate Enteric Coating Materials

Enteric Coated Whey Protein

Active Comparator group

Description:

200kcal whey protein in enteric coating as single dose

Treatment:

Dietary Supplement: Whey Protein in Enteric Coating

Non-Enteric Coated Whey Protein

Placebo Comparator group

Description:

200kcal whey protein with separate enteric coating materials as single dose

Treatment:

Dietary Supplement: Whey Protein with Separate Enteric Coating Materials

Enteric Coated Pea Protein

Active Comparator group

Description:

200kcal pea protein in enteric coating as single dose

Treatment:

Dietary Supplement: Pea Protein in Enteric Coating

Non-Enteric Coated Pea Protein

Placebo Comparator group

Description:

200kcal pea protein with separate enteric coating materials as single dose

Treatment:

Dietary Supplement: Pea Protein with Separate Enteric Coating Materials