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Fructose Dietary then Glucose Dietary for Type 2 Diabetes

N/A

Waitlist Available

Led By Ryan Walker

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 3

Awards & highlights

Study Summary

This trial aims to understand how high fructose consumption affects metabolic health by studying its impact on the gut microbiome. The research team will investigate how excess fructose may lead to changes in the gut microbi

Who is the study for?

This trial is for adults with Type 2 Diabetes, Mesenteric Artery Stenosis, or Obesity. Participants will be tested on how a high fructose diet versus a glucose diet affects their gut microbiome and metabolic health. They should not have conditions that interfere with the study's dietary requirements.Check my eligibility

What is being tested?

The study tests the effects of a controlled high fructose diet compared to a glucose diet on participants' gut bacteria and metabolism. It involves consuming specific diets for 12 days, followed by a washout period, then switching diets. The impact on liver fat and diabetes risk markers will also be studied using advanced techniques like MRI elastography.See study design

What are the potential side effects?

Potential side effects may include changes in digestion due to different sugar intake which could affect gut comfort and function. There might also be alterations in blood sugar levels affecting overall energy and mood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Degree of fibrosis

Liver proton density fat fraction (PDFF)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Glucose Dietary then Fructose DietaryExperimental Treatment2 Interventions

Participants that will be randomized to the 12-day isocaloric weight-maintaining high glucose diet, then will change to the12-day isocaloric weight-maintaining high fructose diet after a 10-day washout period.

Group II: Fructose Dietary then Glucose DietaryExperimental Treatment2 Interventions

Participants that will be randomized to the 12-day isocaloric weight-maintaining high fructose diet, then will change to the 12-day isocaloric weight-maintaining high glucose diet after a 10-day washout period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fructose

2019

N/A

~790

glucose

2013

Completed Phase 4

~440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

525,246 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,561 Total Patients Enrolled

Metabolic Solutions Inc.Industry Sponsor

4 Previous Clinical Trials

152 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study include individuals who are 55 years old and above?

"Eligibility for participation in this research demands that individuals fall within the age bracket of 25 to 45 years. Notably, there are a total of 194 trials catering to minors and 977 geared towards the elderly population."

Answered by AI

What are the eligibility criteria for individuals seeking to participate in this clinical study?

"Individuals aged between 25 and 45 with a confirmed diagnosis of type 2 diabetes are eligible to participate in this study, which aims to enroll approximately 30 participants."

Answered by AI

Is the enrollment for this study currently open?

"According to details on clinicaltrials.gov, the current status of this medical trial indicates that recruitment is not ongoing. The trial listing was initially shared on April 15th, 2024 and underwent its last revision on March 18th, 2024. Despite this particular study no longer accepting applicants, there are approximately 1407 other trials actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Fructose Diet, the Gut Microbiome, and Metabolic Health

Ryan Walker 2024. "High Fructose Diet, the Gut Microbiome, and Metabolic Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06329544.