Overview

This trial is active, not recruiting.

Condition diabetes
Treatments dietary: saccharin, estimate glucose absorptions
Phase phase 1
Sponsor Translational Research Institute for Metabolism and Diabetes, Florida
Collaborator Sanford-Burnham Medical Research Institute
Start date August 2014
End date January 2017
Trial size 20 participants
Trial identifier NCT02835859, TRIMD FH 607060

Summary

The purpose of this study is to collect data that will help researchers better understand the various causes of obesity and diabetes; particularly to understand how consumption of NCASs affects the way the body uses nutrients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Participants will be randomly assigned to drink two oral solutions made of different combinations of saccharin, lactisole, acetaminophen, 3-O-methyl glucose, or glucose.
dietary: saccharin
Assess the glycemic and hormonal responses to an oral glucose load preceded by an oral solution of NCASs (saccharin).
estimate glucose absorptions
Indirectly estimate the rate of glucose absorption and gastric emptying by using 3-O-methyglucose (3-OMG) and acetaminophen, respectively.

Primary Outcomes

Measure
Measure in glucose concentrations
time frame: Measure over a 180 minute on Days 10, 15, 20, 25

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Age 18-65 years inclusive; 2. Men and women; 3. Able to provide written, informed consent; 4. Weight stable (± 3 kg) during the 3 months prior to enrollment; 5. BMI ≤ 25 kg/m2 Exclusion Criteria: 1. Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or chronic obstructive pulmonary disorder, g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder; 2. Consumption of more than a can of diet beverage or a spoonful of non-caloric artificial sweeteners weekly (or each equivalent from foods) during the past month. 3. Pregnant or nursing women; 4. Current smokers (smoking within the past 3 months); 5. Known hypersensitivity to saccharin, lactisole, and acetaminophen or any of its exipients; 6. History of difficult blood sample collections or unfavorable anatomy of venous access; 7. Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents. 8. Blood pressure greater than or equal to 160/100 or less than or equal to 100/50 at screening.

Additional Information

Official title Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners
Principal investigator George Kyriazis, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Translational Research Institute for Metabolism and Diabetes, Florida.