100 Participants NeededMy employer runs this trial

Insulin for Insulin Resistance

LN
Overseen ByLuke Norton, Ph.D
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how insulin affects cells in individuals with normal blood sugar levels. Researchers aim to understand how insulin signals and glucose uptake (how the body uses sugar) can alter certain genes in muscle cells. The study involves administering insulin to observe these effects. Participants should have a stable weight, normal blood sugar, and no recent use of specific medications such as steroids or SGLT2 inhibitors. This trial may suit those who have maintained a stable weight and do not have serious health conditions like high blood pressure or liver issues.

As an unphased study, this trial provides a unique opportunity to contribute to foundational research on insulin's effects.

What prior data suggests that this protocol is safe?

Research has shown that insulin treatments are usually safe for people. The FDA has approved insulin for managing diabetes, confirming its safety through testing. In studies, most people using insulin did not experience serious side effects. However, some might encounter mild issues like low blood sugar. Monitoring blood sugar levels while using insulin is important to avoid this. Patients should always consult their doctor about any concerns to understand how insulin might affect them personally.12345

Why are researchers excited about this trial?

Unlike standard treatments for insulin resistance that often focus on lifestyle changes or medications like metformin and thiazolidinediones, this approach uses insulin itself in a controlled delivery method. Researchers are excited because the insulin 80mU/m2*min euglycemic/hyperinsulinemic clamp technique allows for precise control of insulin levels, potentially offering more immediate and controlled management of insulin resistance. This could be particularly beneficial for patients who do not respond well to current treatments, providing a more tailored and effective approach to managing their condition.

What evidence suggests that insulin might be an effective treatment for insulin resistance?

Research shows that insulin can improve insulin resistance by enhancing cellular response to insulin. In this trial, participants will receive an insulin-stimulated treatment using an 80mU/m2*min euglycemic/hyperinsulinemic clamp to assess its effectiveness. Studies employing precise methods to measure insulin effectiveness have shown promising results. Insulin treatments help the body use insulin more effectively to control blood sugar levels, which is crucial for those struggling to manage their blood sugar. Other methods, such as time-restricted eating and exercise, also support insulin's role in improving sugar metabolism. Overall, insulin has potential in managing insulin resistance by optimizing sugar control in the body.678910

Who Is on the Research Team?

LN

Luke Norton, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for adults who are being studied for how their muscles respond to insulin. Specific inclusion and exclusion criteria are not listed, but generally participants should be healthy enough for muscle biopsies and insulin testing.

Inclusion Criteria

I am between 18 and 75 years old.
Body Mass Index (BMI) > 18
Normal glucose tolerance defined by fasting blood sugar < 100 mg/dL and 2-hour Oral Glucose Tolerance Test (OGTT) < 140 mg/dL
See 6 more

Exclusion Criteria

Partial thromboplastin time (PTT) > 35
International normalized ratio (INR) > 1.2
Urine albumin excretion > 300 mg/day
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo euglycemic/hyperinsulinemic clamp procedures with skeletal muscle biopsies

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Insulin 80mU/m2*min

Trial Overview

Researchers will give participants a controlled dose of insulin through an IV while keeping blood sugar steady, then take muscle samples to study genetic responses in the cells using advanced sequencing techniques.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Insulin stimulatedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

(PDF) Assessment of insulin sensitivity/resistance

The results were comparable to data obtained with more complicated techniques, such as the insulin clamp and suppression tests,

HOMA-IR Score & Calculation

A higher HOMA-IR score means more insulin is required to maintain the same glucose level, indicating greater insulin resistance.

The effectiveness of fasting in combating insulin resistance ...

Current experimental and clinical data indicate that fasting can lower body weight, improve insulin sensitivity, and lead to beneficial effects ...

Time-Restricted Eating and Blood Sugar Regulation

So we can conclude that independent of changes in body weight and fat mass, TRE improves insulin sensitivity in people who are insulin resistant ...

Insulin and Insulin Resistance: The Ultimate Guide

Insulin resistance happens when your cells stop responding properly to insulin, causing your pancreas to produce more insulin to regulate blood sugar (blood ...

New Study Reveals Insulin Resistance in Type 2 Diabetes

The study, conducted by a team of endocrinologists and metabolic researchers, analyzed data from over 10,000 participants across multiple ...

(PDF) Assessment of insulin sensitivity/resistance

Insulin resistance is one pretty troublesome entity which very commonly aggravates metabolic syndrome. It is essential to test and validate ...

Insulin Resistance With Normal Blood Sugar

Below 5 mIU/L: Optimal insulin sensitivity. This is what we see in metabolically healthy individuals. 5 to 8 mIU/L: Acceptable range. Still insulin sensitive ...

Effects of Amount, Intensity, and Mode of Exercise Training ...

The hallmarks of insulin resistance include increased fasting insulin and changes in the lipid profile, such as increased triglycerides and decreased high ...

Insulin Resistance in Healthy U.S. Adults: Findings from the ...

HOMA-IR levels in a large sample of normal individuals are associated with poorer general health and adverse changes across a wide range of markers.