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Amino Acid Supplement

Oral Supplement for Type 2 Diabetes

N/A
Waitlist Available
Research Sponsored by Texas A&M University
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 0, 10, 20, 40, 60, 120 ± 5 min after isotope infusion
Awards & highlights

Study Summary

This trial is testing whether isoleucine affects TCA cycle function in obese, insulin resistant type 2 diabetics, and whether this can help control and coordinate complex patterns of force.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 10, 20, 40, 60, 120 ± 5 min after isotope infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 10, 20, 40, 60, 120 ± 5 min after isotope infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in whole-body protein metabolism in type 2 diabetic obese subjects
Secondary outcome measures
24-hour glucose levels in type 2 diabetic obese subjects
Changes in attention and executive functions as measured by Brief-A in type 2 diabetics obese subjects
Changes in attention and executive functions as measured by Trail Making Test (TMT) in type 2 diabetics obese subjects
+6 more
Other outcome measures
Group differences in Bi-manual Coordination Task between type 2 diabetics and non-diabetic subjects
Group differences in Reaction Time task between type 2 diabetics and non-diabetic subjects
Group differences in balance between type 2 diabetics and non-diabetic subjects
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: IsoleucineExperimental Treatment1 Intervention
Type 2 Diabetics randomized to isoleucine group
Group II: HealthyActive Control1 Intervention
gender-, age-, BMI-matched controls for baseline measurements only. No supplementation provided.
Group III: PlaceboPlacebo Group1 Intervention
Type 2 Diabetics randomized to placebo group

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
140 Previous Clinical Trials
24,016 Total Patients Enrolled

Frequently Asked Questions

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

What is the total number of enrollees in this experiment?

"That is correct. Information available on clinicaltrials.gov demonstrates that this clinical trial is looking for participants. This trial was first posted on May 30th, 2019 and was last updated on December 10th, 2021. The study needs a total of 90 patients from 1 site."

Answered by AI

Could I help researchers by participating in this clinical trial?

"Up to 90 patients between the ages of 45 and 84 who have type 2 diabetes mellitus may be enrolled in this trial. Other inclusion criteria that potential patients must meet are as follows: a clinical diagnosis of type-II diabetes, current oral glucose lowering medication or insulin use, a stable body weight within the past 3 months, a BMI of 28 kg/m2 or higher, satisfactory health based on medical history and physical examination, the ability to walk, sit, and stand independently, the ability to lie in supine or elevated position for 10 hours or less, and a willingness to comply with the protocol."

Answered by AI

Are we only testing this new medication on young adults?

"This particular study is only recruiting patients that are between 45 and 84 years old. In contrast, there are 195 studies that focus on children and 1160 studies for elderly patients."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes
Marielle PKJ Engelen, PhD 2019. "Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04461236.
All > Type 2 Diabetes
~15 spots leftby Apr 2025
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