Hydration for Diabetes

(HYDRATE Trial)

Overseen By Holly Emmanuel, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Thyroid, GLP1-RA, SSRI, Testosterone

Disqualifiers: Diabetes, Cancer, Renal, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether increasing water or non-sugar drink intake can improve heart health and help manage blood sugar levels in adults. It targets individuals who are either of normal weight or have obesity, specifically those without diabetes but at risk for it. Participants will test different levels of water and non-sugar drink intake to determine if better hydration, known as Adequate Hydration, benefits their health. Ideal candidates have maintained a stable weight recently and can commit to consistent participation over eight weeks. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research on hydration and health.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, such as thyroid medication, aspirin, medications affecting appetite or body weight, GLP1-RA, SSRI antidepressants, and testosterone replacement therapy. If you are on any of these, you would need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that drinking the right amount of water is generally safe and important for maintaining health. Studies indicate that staying hydrated can lower the risk of health problems. For instance, drinking enough water each day can help manage blood sugar levels and may reduce the risk of type 2 diabetes.

Regarding non-sugar sweeteners in drinks, some research suggests they can be a safe alternative to sugar. They might even aid in weight control and lower the risk of heart disease. However, opinions on non-sugar sweeteners vary, and some studies suggest more research is needed to confirm their long-term safety.

Overall, drinking enough water, whether plain or with non-sugar sweeteners, is considered safe for most people. It's an easy way to support good health without adding extra calories. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the hydration strategies being studied for diabetes management because they introduce a non-pharmacological approach to managing blood sugar levels. Unlike traditional diabetes treatments, which often involve medications like insulin or oral hypoglycemics, these strategies focus on varying fluid intake levels, both with and without non-caloric sweeteners. This method might offer a more natural, accessible option for individuals, potentially enhancing hydration habits and improving glucose control without medication. By exploring how different levels of fluid intake impact diabetes, researchers hope to uncover a simple yet effective lifestyle change that could complement existing treatment options.

What evidence suggests that this trial's treatments could be effective for diabetes?

Research shows that drinking enough water can help manage diabetes. One study found that people who drank more water had a much lower chance of developing high blood sugar, a major problem in diabetes. Another study showed that diabetic patients who stayed well-hydrated could control their blood sugar levels more effectively. Drinking plain water has also been linked to a lower risk of developing type 2 diabetes. Additionally, drinking more water reduced the amount of food energy consumed by about 13%, aiding weight management. This trial will explore various hydration strategies, including low, moderate, and adequate water intake, as well as fluid intake with non-caloric sweeteners, to assess their impact on diabetes management. These findings suggest that staying properly hydrated might help in managing and possibly preventing diabetes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults who are either normal-weight or obese, looking to improve their hydration and health outcomes. It's not specified who can't join the trial, but typically those with conditions affecting fluid balance or metabolism might be excluded.

Inclusion Criteria

My BMI is either between 18.5-24.9 or 30.0-39.9.

I am between 20 and 65 years old.

HbA1c ≤7%

Exclusion Criteria

I have a heart condition.

I am currently taking medication for an infection.

I do not have chronic infectious diseases like TB or hepatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Baseline

Participants maintain their habitual fluid intake without any intervention

1 week

1 visit (in-person)

Treatment

Participants undergo an 8-week crossover study with controlled fluid intake, alternating between plain water and non-sugar-sweetened beverages

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adequate Hydration

Trial Overview The study tests how different levels of water intake affect health. Over eight weeks, participants will try varying amounts of water and non-caloric sweetened drinks to see if these impact cardiovascular health and glucose regulation.

How Is the Trial Designed?

Group I: Washout period - week 5 Experimental Treatment 1 Intervention

Habitual fluid intake week

Group II: Moderate water intake - week 3 Experimental Treatment 1 Intervention

Moderate water intake as described by the protocol

Group III: Moderate fluid intake with non caloric sweeteners - Week 7 Experimental Treatment 1 Intervention

Moderate fluid intake with non caloric sweeteners - Week 7

Group IV: Low fluid intake with non caloric sweeteners - Week 6 Experimental Treatment 1 Intervention

Low fluid intake with non-caloric sweeteners - Week 6

Group V: Low Water intake - week 2 Experimental Treatment 1 Intervention

Low water intake as described by the protocol

Group VI: Baseline - week 1 Experimental Treatment 1 Intervention

Habitual fluid intake during week 1 of the study

Group VII: Adequate fluid intake with non caloric sweeteners - Week 8 Experimental Treatment 1 Intervention

Adequate fluid intake with non caloric sweeteners - Week 8

Group VIII: Adequate Water intake - Week 4 Experimental Treatment 1 Intervention

Adequate water intake as described by the protocol

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11589796/

Outcomes in Randomized Clinical Trials Testing Changes ... They found a statistically significant 13% reduction in meal energy intake with water preload. A psychosocial benefit may also exist, in which ...

2. japi.org japi.org/article/japi-72-6-s1-16

Diabetes Mellitus and Fluid Imbalance: The Need for ... This study concluded that lowered water intake was inversely and independently associated with the risk of developing hyperglycemia. Reduced ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468227624000590

A study of biomarkers associated with insulin resistance in ... There was a reduction in adiponectin expression in both groups after the duration of improved water intake. Glucose concentration decreased significantly (p< ...

4. news.asu.edu news.asu.edu/20190514-discoveries-watering-down-diabetes

Watering down diabetes | ASU News They found that diabetic patients were able to regulate their glucose levels significantly better when they were properly hydrated. To ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5197923/

An investigation into the relationship between plain water ... A small cross-sectional study in the UK found that 1 cup (240 ml)/d of plain water was linearly associated with a 0·72-point reduced T2D risk (based on a 0–47- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11426959/

Non-sugar sweeteners: helpful or harmful? The challenge ... Exposure to non-sugar sweeteners early in life is associated with increased body fat and cardiometabolic risk factors in observational studies, ...

7. diabetesjournals.org diabetesjournals.org/care/article/46/9/1681/153434/Artificial-Sweeteners-and-Risk-of-Type-2-Diabetes

Artificial Sweeteners and Risk of Type 2 Diabetes in the ... This study provides important insights in the context of on-going reevaluation of artificial sweeteners by health authorities worldwide.

8. bmj.com bmj.com/content/364/bmj.k4718

Association between intake of non-sugar sweeteners and ... Some studies report an association between NSS use and reduced risk of type 2 diabetes, overweight, and obesity (thus suggesting a benefit for general health)

9. nature.com nature.com/articles/s41430-023-01314-7

WHO guideline on the use of non-sugar sweeteners This study found a 12% decrease in coronary heart disease risk by replacing sugar-sweetened beverages with NSS beverages. This study was ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352154616300626

Not-so-healthy sugar substitutes? It has been estimated that over 10 years, sugar sweetened beverage consumption could contribute to up to 2.6 million cases of type 2 diabetes in the U.S. alone ...