Trial Search Results

Relationship Between Insulin Resistance and Statin Induced Type 2 Diabetes, and Integrative Personal Omics Profiling

There is general agreement that statin-treatment of patients with high cholesterol can increase the incidence of type 2 diabetes (T2DM) in some individuals. This research proposal will study what metabolic characteristics and variables (for example high cholesterol or high triglycerides or both) will identify those people at highest risk of statin-induced T2DM. The investigators will evaluate how the medication atorvastatin (trade name Lipitor) works in regards to its effect on insulin action and insulin sensitivity to help further understand the possible cause of the increased occurrences of T2DM in people who are at risk for T2DM.

Under Dr. Snyder, a Co-director of the study, samples will be collected for integrated Personal Omics Profiling (iPOP), a monitoring approach developed by Dr. Snyder and his research colleagues. The investigators propose to analyze iPOP of individuals who participate in this study during and after taking the statin. In this pilot study, analysis will be done on previously-known drug effectiveness but also untargeted drug's effectiveness, (other unknown benefits this medication may have) and drug effects such as those seen in some participants when given a statin. The hope then is to obtain a better understanding of how to perform a personal omics profile when taking drugs, which would lead to develop better use of drugs.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Atorvastatin

Phase:

Phase 4

Eligibility


Inclusion Criteria:

   1. Healthy adults 30- 65 years old,

   2. BMI 25-35 kg/m2,

   3. nondiabetic as defined by fasting plasma glucose <126 mg/dL

   4. Lipids: one group with an LDL =/>130 and Triglycerides < 150 mg/dL The 2nd group will
   have and LDL=/>130 mg/dL and Triglycerides =/>150 mg/dL but less than 400 mg/dL.

No one will be on any statin therapy before entering the study. 5. One risk factor for type
2 diabetes as outlined by ADA 2015 guidelines

Exclusion Criteria:

   1. Less than 30 yrs of age or > 65 yrs of age

   2. Any significant co-morbidities, such as active heart, kidney, or liver diseases,
   accelerated or malignant hypertension, heart failure, severe anemia.

3 Cannot be taking any medications intended for weight loss, or those known to influence
insulin sensitivity.

4.Pregnancy/ lactation is an exclusion, as are women unwilling to use an effective birth
control method. 5. History of statin intolerance to all statins

Ages Eligible for Study

30 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cindy Lamendola, MSN, NP
650-723-3141
Recruiting