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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
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
Study Summary
This trial will test whether weight reduction can help people who are insulin resistant and have a family history of type 2 diabetes by improving their insulin sensitivity.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,341 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
2,359 Previous Clinical Trials
4,314,492 Total Patients Enrolled
87 Trials studying Insulin Resistance
13,125 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative open to elderly individuals?
"This clinical trial is open to all adults aged 18-90. In addition, there are 51 studies available for minors and 290 ones geared towards seniors."
Answered by AI
How many participants are involved in the current investigation?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial has been open since October 1st 2002 and was recently updated on January 17th 2022. The research team is currently looking for 100 volunteers to partake in the study at one site."
Answered by AI
Could I qualify to be a participant in this investigation?
"This medical investigation is recruiting 100 patients suffering from insulin resistance between 18 and 90 years of age. To be eligible, they must meet the following conditions: haematocrit higher than 35%, no systemic or organ diseases (including diabetes), contraception use if female and cycling in days 0-7, absence of eating disorders, non-smoking status as well as abstention from medications other than birth control pills. Furthermore, physical activity will be evaluated through a questionnaire with an index cutoff at 2.3"
Answered by AI
Are new participants still being accepted for this medical experiment?
"The information on clinicaltrials.gov reveals that recruitment is still ongoing for this investigation, which had its inaugural posting on October 1st 2002 and was amended most recently on January 17th 2022."
Answered by AI
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