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Behavioral Intervention

Ketogenic vs Low Fat Diet for Type 2 Diabetes Prevention (KDDP Trial)

Q: What is the current availability of this clinical trial for potential participants?

<p>Affirmative. Clinicaltrials.gov hosts the data that verifies this medical trial is actively recruiting qualified candidates, having first been posted on September 5th 2023 and most recently updated on October 30th of the same year. 40 participants need to be enrolled from 1 clinical site.</p>

Q: What is the headcount of participants engaging in this research?

<p>Affirmative, the information available on clinicaltrials.gov states that this medical research is presently recruiting volunteers. This trial was initially posted on September 5th 2023 and has underwent its most recent update on October 30th 2023. The investigation requires 40 patients to be recruited from a single site of study.</p>

N/A

Recruiting

Led By Kristen Gonzales, MD

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

KDDP Trial Summary

This trial will compare the effectiveness of two diets for diabetes prevention: a ketogenic diet and a low fat diet.

Who is the study for?

This trial is for men and women over 18 with type 2 diabetes or prediabetes, who have a BMI of 27 or higher. It's not for pregnant individuals, those with type 1 diabetes, very high LDL cholesterol or triglycerides, history of serious heart conditions, insulin users, or people with advanced kidney/liver disease or terminal cancer.Check my eligibility

What is being tested?

The study compares two diets: a medically-supervised ketogenic diet (KDDP) versus a low fat diet (NDPP). Over the course of one year, it will measure their effects on blood sugar control, cholesterol levels, blood pressure, heart rate, weight loss and heart artery health.See study design

What are the potential side effects?

Potential side effects from the ketogenic diet may include nutrient deficiencies if not properly managed. The low-fat diet could lead to hunger due to reduced calorie intake. Both diets might cause changes in bowel habits.

KDDP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Weight in kg

Secondary outcome measures

Blood pressure in mmHg

CAC scores

Fasting lipids in mg/dL

+3 more

KDDP Trial Design

2Treatment groups

Experimental Treatment

Group I: NDPPExperimental Treatment1 Intervention

NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.

Group II: KDDPExperimental Treatment1 Intervention

KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (<20 grams of carbohydrate/day).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low Fat diet

2004

Completed Phase 2

~50

Ketogenic diet

2020

N/A

~680

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor

372 Previous Clinical Trials

3,528,749 Total Patients Enrolled

Kristen Gonzales, MDPrincipal InvestigatorUniversity of New Mexico

Frequently Asked Questions

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

What is the current availability of this clinical trial for potential participants?

"Affirmative. Clinicaltrials.gov hosts the data that verifies this medical trial is actively recruiting qualified candidates, having first been posted on September 5th 2023 and most recently updated on October 30th of the same year. 40 participants need to be enrolled from 1 clinical site."

Answered by AI

What is the headcount of participants engaging in this research?

"Affirmative, the information available on clinicaltrials.gov states that this medical research is presently recruiting volunteers. This trial was initially posted on September 5th 2023 and has underwent its most recent update on October 30th 2023. The investigation requires 40 patients to be recruited from a single site of study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketogenic Diet and Diabetes Demonstration Project

Kristen M Gonzales 2023. "Ketogenic Diet and Diabetes Demonstration Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06115265.

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