NCT03944616Completed
Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes
Effect of Artificially Sweetened Beverages on Diabetes Control in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
Diet beverages sweetened with artificial sweeteners occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories. Diet beverages are the single largest contributor to artificial sweetener intake in the U.S. diet, and people with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages. This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control. The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes; therefore randomized trials with relevant outcomes must be conducted because they would address many limitations of previous research and have major implications for dietary recommendations on diet beverage intake and primary and secondary prevention of chronic disease. To begin addressing this important scientific gap the investigators are testing the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 24-weeks. This study will recruit 200 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily). The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c). The study will also measure the nature and magnitude of glycemic excursions via continuous glucose monitors, as well as clinical markers of cardiometabolic risk and kidney function. Lastly, investigators will measure plausible mechanisms whereby diet beverage intake may alter risk by assessing the effect of diet beverage intake on the functional composition of the gut microbiome via stool samples and comprehensive metabolomics, satiety hormones, as well as usual dietary intake, and upstream behavioral pathways which may inform dietary intake patterns.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 181 (actual)
- First submitted
- 19 Nov 2018
- Start date
- 6 Jun 2019
- Primary completion date
- 21 Mar 2024
- Lead sponsor
- University of California, Irvine
- Diseases
- Type 2 diabetes
- NCT number
- NCT03944616
What you commit to
- Study type: Interventional
- Participants enrolled: 181
- From 6 Jun 2019 to the primary completion date, 21 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous randomization in this study,
Other illness
- Type 1 diabetes or suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin)
- "Secondary" diabetes due to specific causes (e.g. monogenic syndromes, pancreatic surgery, and pancreatitis)
- History of intolerance or allergy to diet beverages or AS or phenylketonuria
- Major cardiovascular disease event or surgery within past 6 months
- Gastrointestinal disease
- Renal or liver disease
- Current treatment for cancer
- Those with major surgery planned or history of bariatric surgery
Lab values
- Any condition that is known to affect the validity of the glycemic measures (Hba1c)
Other
- Diabetic Ketoacidosis hospitalization within last 6 months
- Severe/major hypoglycemia in the last 3 months-severe/major hypoglycemia is defined as a hypoglycemic event in which patient requires assistance of another person to manage the episode
- Glucocorticoid use (prednisone 2.5 mg/d or more or its equivalent)
- Antibiotic treatment (\> 6 days) within past 6 months
- Currently pregnant (via self-report) or planning to become pregnant during study period; \<1 year postpartum and breast feeding
- Current participation in another interventional clinical trial
- Heavy alcohol consumption (on average \>2 drinks/day for women and \>3 drinks/day for men)
- Habitual consumer of SSB ≥ 1 serving / day (8 oz.)
- Does not drink diet beverages
- BMI \< 20.0 kg/m2
Who the study is looking for
- Physician diagnosed type 2 diabetes ≥ 6 months prior to screening
- HbA1c 6.5-8.5% at participant screening
- Current treatment with lifestyle changes or stable diabetes-related medication levels for the past 3 months
- Willingness to provide consent to contact treating physician and physician agreement to refrain from changing diabetes-related medications during the trial (change defined as \> 2 fold change in dose of any 1 hyperglycemic agent or addition or subtraction of an agent)
- No physician-directed medication change for 3 months if prescribed medication for lipids or blood pressure
- Usual consumers of diet beverages (≥ 3 servings/ week (24 oz.) and the willingness to maintain fidelity of the intervention, and participate in all aspects of the intervention
- Not actively looking to make major lifestyle alterations during the study period with stable weight for 2 months (within 3%).
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.