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New treatment option for Insulin Resistance
Official title Reversal of Lipid-Induced Insulin Resistance
ClinicalTrials.gov ID: NCT02193295
What this study is testing
- What it's testing
- The purpose of this study is to examine whether weight reduction decreases intramyocellular (IMCL) and hepatic lipid content, and improves insulin sensitivity of muscle and fat tissue in people who are insulin resistant and have a family history of type 2 diabetes. Hepatic mitochondrial oxidation will be assesses using a 3 hour triple tracer study (D7 glucose, 3-13C lactate and 13C4 beta-hydroxybutyrate).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90. Healthy volunteers may be eligible.
You may be able to join if
- Healthy, sedentary, non-smoking and not taking any medications other than birth control pills.
- Hematocrit \>35%
- people will have no systemic or organ disease including diabetes.
- people will have no history eating disorders.
- Women must be using a form of birth control (sexual abstinence, birth control pills, Norplant, IUD or condoms) and will be studied between day 0 and...
You likely can't join if
- Any subject, who does not fit the inclusion criteria. Including history of eating disorders, any systemic and organ disease including diabetes...
- Hematocrit \<35%.
- Women of childbearing potential, who are not using contraception (as mentioned above) or who are not abstinent.
- people who have a regular exercise regimen will not be enrolled.
- Metal implants and/or body piercing, which cannot be removed before the MR studies.
See the full eligibility criteria
- Healthy, sedentary, non-smoking and not taking any medications other than birth control pills.
- Hematocrit \>35%
- people will have no systemic or organ disease including diabetes.
- people will have no history eating disorders.
- Women must be using a form of birth control (sexual abstinence, birth control pills, Norplant, IUD or condoms) and will be studied between day 0 and 7 of their menstrual cycle.
- Those who are taking birth control pills or have had a hysterectomy may be studied at any time.
- Physical activity will be assessed using a standard questionnaire with an activity index cut off at 2.3.
- Any subject, who does not fit the inclusion criteria. Including history of eating disorders, any systemic and organ disease including diabetes. Lactose intolerance Any blood count, clotting abnormalities...
- Hematocrit \<35%.
- Women of childbearing potential, who are not using contraception (as mentioned above) or who are not abstinent.
- people who have a regular exercise regimen will not be enrolled.
- Metal implants and/or body piercing, which cannot be removed before the MR studies.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.