What side effects are associated with this type of intervention?

Common treatments for insulin resistance, such as weight reduction through diet and exercise, are generally safe but may lead to nutritional deficiencies or muscle loss if not properly managed. Medications like metformin can cause gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Thiazolidinediones may lead to weight gain, fluid retention, and an increased risk of heart failure. GLP-1 receptor agonists, which also aid in weight loss, may cause gastrointestinal side effects and, rarely, pancreatitis.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of insulin resistance, focusing on improving insulin sensitivity and reducing lipid content in muscle and liver tissues. Metformin is a widely used first-line treatment that enhances insulin sensitivity and reduces hepatic glucose production. GLP-1 receptor agonists, such as liraglutide and semaglutide, not only improve glycemic control but also promote weight loss and reduce hepatic steatosis. Thiazolidinediones, including pioglitazone and rosiglitazone, improve insulin sensitivity by reducing lipid content in muscle and liver tissues. These drugs have shown efficacy in clinical trials and are commonly used in managing type 2 diabetes and associated insulin resistance.

What other types of research exist?

Promising novel alternatives to weight reduction for improving insulin sensitivity in insulin-resistant patients include: 1) Metformin, which reduces visceral and abdominal fat and improves glycemic control. 2) Thiazolidinediones, such as pioglitazone, which increase limb fat and improve insulin sensitivity, though they require careful monitoring of liver enzymes. 3) GLP-1 receptor agonists, which enhance insulin secretion and have beneficial effects on weight and lipid metabolism. 4) SGLT2 inhibitors, which reduce glucose reabsorption in the kidneys and have shown benefits in reducing liver fat and improving insulin sensitivity.

← Back to Search

ACC Inhibitor

Caloric Restriction for Insulin Resistance

N/A

Recruiting

Led By Kitt Petersen, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Subjects will have no systemic or organ disease including diabetes

Healthy, sedentary, non-smoking, and not taking any medications other than birth control pills

Must not have

Women of childbearing potential who are not using contraception (as mentioned above) or who are not abstinent

Any subject who does not fit the inclusion criteria, including history of eating disorders, any systemic and organ disease including diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating if losing a small amount of weight can help people who are at risk for diabetes because of their family history. The study focuses on lean individuals who have trouble using insulin properly. By reducing fat in their muscles and liver, the researchers hope to improve their body's response to insulin and better manage blood sugar levels.

Who is the study for?

This trial is for healthy, non-smoking adults who are sedentary, not on medications (except birth control), and have a family history of type 2 diabetes but do not have it themselves. They should be free from systemic diseases, eating disorders, and regular exercise routines. Women must use contraception and can participate at certain times based on their menstrual cycle or contraceptive use.

What is being tested?

The study is testing if losing weight through caloric restriction can reduce fat in the liver and muscles and improve insulin sensitivity in people with insulin resistance. It involves detailed assessments including a triple tracer study to measure hepatic mitochondrial oxidation.

What are the potential side effects?

While specific side effects are not listed for caloric restriction, participants may experience fatigue, hunger, mood changes, or nutrient deficiencies due to reduced food intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have diabetes or any other systemic or organ disease.

Select...

I am healthy, don't smoke, lead a sedentary lifestyle, and only take birth control pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a woman who can have children and am not using birth control or practicing abstinence.

Select...

I do not have eating disorders, diabetes, or other systemic diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvements in insulin sensitivity

Side effects data

From 2020 Phase 3 trial • 379 Patients • NCT02432209

29%

Admission to NICU

17%

Gestational Diabetes

13%

Nausea/vomiting

13%

Dysmenorrhea

12%

Pre-eclampsia/Eclampsia

10%

Pre-term labor

10%

Intrauterine growth restriction

10%

Back pain

Anxiety/irritability

Premature rupture of membranes

Placental abnormalities

Abdominal pain

Pregnancy of Unknown Location

Diarrhea

Other complication

Hospitalization-infant

Mood swings

Constipation

Ectopic pregnancy

Post-partum Infection

Placenta Previa and Pre-term birth

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Lifestyle InterventionExperimental Treatment1 Intervention

Caloric Restriction to reverse lipid-induced insulin resistance.

Group II: Baseline Assessment of Hepatic Mitochondrial Fat OxidationExperimental Treatment1 Intervention

Tracer study to assess hepatic mitochondrial fat oxidation (PINTA).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Caloric Restriction

2018

Completed Phase 3

~570

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Weight reduction is a key treatment for insulin resistance, primarily because it decreases lipid content in muscle and liver tissues, thereby improving insulin sensitivity. This is crucial for patients as it enhances the body's ability to use insulin effectively, reducing blood glucose levels and mitigating the risk of developing type 2 diabetes. Other common treatments include pharmacotherapy, such as metformin, which improves insulin sensitivity and reduces glucose production in the liver, and lifestyle interventions like diet and exercise, which further support weight loss and metabolic health.