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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 belowSelect...
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
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 • NCT0243220929%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your physical activity level will be measured using a questionnaire, and you need to have an activity index score of at least 2.3.Your blood tests show any unusual counts or clotting issues.Your blood has high levels of triglycerides (over 100 mg/dL).Your hematocrit level is lower than 35%.I am a woman who can have children and am not using birth control or practicing abstinence.I do not have diabetes or any other systemic or organ disease.You have metal implants or body piercings that cannot be taken out before the MR studies.You cannot digest lactose.I am on birth control pills or have had a hysterectomy.I do not have eating disorders, diabetes, or other systemic diseases.I am healthy, don't smoke, lead a sedentary lifestyle, and only take birth control pills.Your hematocrit level is higher than 35%.You have not had any problems with eating disorders in the past.I am a woman using birth control and can participate in the study during the first week of my menstrual cycle.
Research Study Groups:
This trial has the following groups:- Group 1: Baseline Assessment of Hepatic Mitochondrial Fat Oxidation
- Group 2: Lifestyle Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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