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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
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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 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
7%
Anxiety/irritability
7%
Premature rupture of membranes
7%
Placental abnormalities
6%
Abdominal pain
5%
Pregnancy of Unknown Location
5%
Diarrhea
5%
Other complication
5%
Hospitalization-infant
5%
Mood swings
4%
Constipation
3%
Ectopic pregnancy
3%
Post-partum Infection
2%
Placenta Previa and Pre-term birth
2%
Other post-partum complication(s)
2%
Hospitalization
2%
Post-partum hemorrhage
1%
Appendicitis
1%
Pneumonia
1%
Complex cyst resulting in surgical intervention
1%
Pulmonary Embolism
1%
Flatulence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Lifestyle Intervention
Intensive Lifestyle Mod. Intervention

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

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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,919 Previous Clinical Trials
3,040,255 Total Patients Enrolled
26 Trials studying Insulin Resistance
5,311 Patients Enrolled for Insulin Resistance
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,439 Previous Clinical Trials
4,324,724 Total Patients Enrolled
93 Trials studying Insulin Resistance
13,372 Patients Enrolled for Insulin Resistance
Kitt Petersen, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
41 Total Patients Enrolled
1 Trials studying Insulin Resistance
41 Patients Enrolled for Insulin Resistance

Media Library

ACC Inhibitor (ACC Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02193295 — N/A
Insulin Resistance Research Study Groups: Baseline Assessment of Hepatic Mitochondrial Fat Oxidation, Lifestyle Intervention
Insulin Resistance Clinical Trial 2023: ACC Inhibitor Highlights & Side Effects. Trial Name: NCT02193295 — N/A
ACC Inhibitor (ACC Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02193295 — N/A
~31 spots leftby Oct 2034