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5-2 CR for Diabetes

N/A
Waitlist Available
Led By Dimitrios I Kapogiannis, M.D.
Research Sponsored by National Institute on Aging (NIA)
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 week 0, week 4, week 8
Awards & highlights

Study Summary

This trial is testing the effects of two different diets on insulin resistance and brain function.

Eligible Conditions
  • Diabetes
  • Obesity
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 4, week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 4, week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) P-pan-Tyrosine-IRS-1 (pY-IRS-1)
Mean Change in Neuron-Derived Extracellular Vesicle (NDEV) Phosphorylated Serine312-insulin Receptor Substrate-1 (pS312-IRS-1)
Secondary outcome measures
Change in the Positive and Negative Affect Schedule (PANAS)
Mean Change in Alanine Aminotransferase (ALT)
Mean Change in Alanine by Proton J-PRESS MRS of Medial Prefrontal Cortex (MPFC)
+87 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 5-2 CRExperimental Treatment1 Intervention
Healthy living diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days/week.
Group II: Healthy Living DietActive Control1 Intervention
Healthy living diet for 7 days/week

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)Lead Sponsor
1,675 Previous Clinical Trials
28,020,796 Total Patients Enrolled
25 Trials studying Diabetes
764,926 Patients Enrolled for Diabetes
Dimitrios I Kapogiannis, M.D.Principal InvestigatorNational Institute on Aging (NIA)
3 Previous Clinical Trials
282 Total Patients Enrolled

Frequently Asked Questions

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

How many people can join this research project?

"Yes, this is an ongoing trial that was first posted on June 22nd, 2015. The study requires 150 patients from a single location and has been edited most recently on October 31st, 2022."

Answered by AI

Does the FDA certify Boost 5-2 diet as a healthy meal plan?

"While there is some evidence indicating that the Boost 5-2 diet is safe, as it is only a Phase 2 trial, there is no concrete data supporting its efficacy. Consequently, our team has given it a score of 2."

Answered by AI

Are researchers seeking elderly participants for this clinical trial?

"The age range this study is recruiting in is between 55 and 70 years old."

Answered by AI

Who meets the requirements to participate in this experiment?

"This clinical trial is recruiting 150 participants with diabetes mellitus aged 55 and 70 who meet the following criteria: - history of eating disorders, significant GI disorders or malabsorption disorders;- HOMA-IR greater than or equal to 1.8; - MMSE greater than or equal to 26; - no clinically significant endocrine disorders (common mild endocrine disorders, such as untreated subclinical hypothyroidism with TSH < 10 mU/l or successfully treated hypothyroidism may be allowed); - no clinically significant stroke or other neurological disease of the central nervous"

Answered by AI

Are there any unfilled vacancies for test subjects in this experiment?

"That is correct. The clinicaltrials.gov website has information showing that this study is still looking for subjects. This trial was originally posted on June 22nd, 2015 and the most recent update was on October 31st, 2022. Currently, they are recruiting for 150 individuals at 1 site."

Answered by AI
~13 spots leftby Apr 2025