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Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes (SODAS)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diet Beverage

Water

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Diet beverages, diet, diabetes control, artificial sweeteners, continuous glucose monitor, gut microbiome, metabolomics

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: We will include men, women and non-binary participants with T2D, age 35 years and older, able to provide informed consent, otherwise healthy, who meet the following criteria:

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%).

Exclusion Criteria:

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)
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)
History of intolerance or allergy to diet beverages or AS or phenylketonuria
Any condition that is known to affect the validity of the glycemic measures (Hba1c)
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
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
Previous randomization in this study,
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

Sites / Locations

University of California, Irvine
University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diet Beverage

Water

Arm Description

Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.

Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.

Outcomes

Primary Outcome Measures

HbA1c

Glycated hemoglobin

Secondary Outcome Measures

Time In Range

Time in range is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Time in Range is defined as the % of time each day with a glucose measure between 70-180 mg/dl. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.

Glycemic Variability

Glycemic variability is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Glycemic variability is defined as the CV and SD. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.

Other CGM metrics

Multiple metrics are able to be calculated by CGM. The primary secondary endpoint for CGM will be Time In Range. Reporting of any other CGM metrics will be prefaced with this statement and the residual CGM metrics will be analyzed and interpreted cautiously and conservatively. They include: Mean glucose, glycemic variability, and episodes of hypoglycemia/hyperglycemia.

Lipid panel (Total cholesterol, LDL cholesterol, HDL cholesterol, Fasting Triglycerides), all mg/dL

A lipid panel is a standard measurement for assessing clinical CVD risk

Kidney function

Serum creatinine is a standard clinical measurement for kidney function

Fasting glucose and Insulin

Standard clinical measures

Fructosamine/Glycated Albumin

Fructosamine and glycated albumin levels represent usual glycemia over the past 2-3 weeks, and are considered valid markers of short term clinical glycemic patterns by the American Diabetes Association

Blood pressure

Systolic and Diastolic blood pressure, standard clinical measurement

Weight (kg)

Weight measured on standardized scale in gown

Dietary Quality (Healthy Eating Index)

Assessed by multiple unannounced 24-hour dietary recalls that will occur during the run-in to assess usual habits (2 recalls over 2 weeks) and the active intervention (5 recalls over 24 weeks), to measure any changes in diet quality metric. Results will be used to calculate a metric of diet quality in the Healthy Eating Index that is based upon the USDA Dietary Guidelines.

DHP-18

A diabetes-specific patient reported outcome measure developed to evaluate the health-related quality of life of people living with type 2 diabetes

Food Craving Inventory

Measures different domains of general and specific food cravings

Sleep Quality and Patterns

Pittsburgh Sleep Quality Index

Physical activity

Objectively measured via Activpal

Serotonin

Chemical and neurotransmitter measured in blood with myriad roles, including appetite and digestion

Leptin

Hormone measured in the blood with satiety related role

Thyroid Stimulating Hormone (TSH)

Hormone measured in the blood with energy balance related role

Neuropeptide Y

Peptide measured in the blood with satiety related role

cholecystokinin (CCK)

Peptide measured in the blood with satiety related role

Gut Microbiome

Measured with kit: Self-collection and stabilization of microbial DNA from feces for gut microbiome profiling

Comprehensive metabolomics

Serum collection for comprehensive metabolomics analysis for integrative analysis with gut microbiome

Dietary Practices

Short questionnaire assessing dietary behaviors related to meal frequency, timing, and eating away from home

Full Information

NCT ID

NCT03944616

First Posted

November 19, 2018

Last Updated

April 28, 2023

Sponsor

University of California, Irvine

Collaborators

University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT03944616

Brief Title

Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes

Acronym

SODAS

Official Title

Effect of Artificially Sweetened Beverages on Diabetes Control in Adults With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

June 6, 2019 (Actual)

Primary Completion Date

March 21, 2023 (Actual)

Study Completion Date

March 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

Collaborators

University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Diet beverages, diet, diabetes control, artificial sweeteners, continuous glucose monitor, gut microbiome, metabolomics

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study is testing the effect of commercial 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. We 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).

Masking

Outcomes Assessor

Masking Description

All nursing staff/phlebotomist collecting physical samples, and the lab analyzing the samples will be masked to the trial arm the participant is in. The biostatistician performing the final analyses will also be masked.

Allocation

Randomized

Enrollment

181 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diet Beverage

Arm Type

Active Comparator

Arm Description

Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.

Arm Title

Water

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Diet Beverage

Intervention Description

Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.

Intervention Type

Behavioral

Intervention Name(s)

Water

Intervention Description

Primary Outcome Measure Information:

Title

HbA1c

Description

Glycated hemoglobin

Time Frame

0, 12, 24 weeks

Secondary Outcome Measure Information:

Title

Time In Range

Description

Time Frame

All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)

Title

Glycemic Variability

Description

Time Frame

All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)

Title

Other CGM metrics

Description

Time Frame

All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)

Title

Lipid panel (Total cholesterol, LDL cholesterol, HDL cholesterol, Fasting Triglycerides), all mg/dL

Description

A lipid panel is a standard measurement for assessing clinical CVD risk

Time Frame

0, 12, 24 weeks

Title

Kidney function

Description

Serum creatinine is a standard clinical measurement for kidney function

Time Frame

0, 6, 12, 18, 24 weeks

Title

Fasting glucose and Insulin

Description

Standard clinical measures

Time Frame

0, 6, 12, 18, 24 weeks

Title

Fructosamine/Glycated Albumin

Description

Time Frame

0, 6, 12, 18, 24 weeks

Title

Blood pressure

Description

Systolic and Diastolic blood pressure, standard clinical measurement

Time Frame

0, 6, 12, 18, 24 weeks

Title

Weight (kg)

Description

Weight measured on standardized scale in gown

Time Frame

0, 6, 12, 18, 24 weeks

Title

Dietary Quality (Healthy Eating Index)

Description

Time Frame

Run-in period (2 weeks), Active intervention (Up to 24 weeks).

Title

DHP-18

Description

A diabetes-specific patient reported outcome measure developed to evaluate the health-related quality of life of people living with type 2 diabetes

Time Frame

0, 6, 12, 18, 24 weeks

Title

Food Craving Inventory

Description

Measures different domains of general and specific food cravings

Time Frame

0, 6, 12, 18, 24 weeks

Title

Sleep Quality and Patterns

Description

Pittsburgh Sleep Quality Index

Time Frame

0, 6, 12, 18, 24 weeks

Title

Physical activity

Description

Objectively measured via Activpal

Time Frame

All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)

Title

Serotonin

Description

Chemical and neurotransmitter measured in blood with myriad roles, including appetite and digestion

Time Frame