ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02437084
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Joshua Knowles, Stanford University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Atorvastatin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Relationship Between Insulin Resistance and Statin Induced Type 2 Diabetes, and Integrative Personal Omics Profiling
Study Start Date : May 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Elevated LDL
Those with elevated LDL =/> 130 mg will receive 40 mg of atorvastatin
Drug: Atorvastatin
study subjects divided into 2 groups as described earlier and both receiving atorvastatin 40 mg for 8 weeks.
Other Name: Lipitor

Elevated LDL and Triglycerides
Those with elevated LDL =/> 130 mg and elevated triglycerides =/> 150 mg will receive 40 mg of atorvastatin
Drug: Atorvastatin
study subjects divided into 2 groups as described earlier and both receiving atorvastatin 40 mg for 8 weeks.
Other Name: Lipitor




Primary Outcome Measures :
  1. Change from baseline in glucose tolerance in two groups, those with elevated LDL-C (mg/dL) versus those with elevated LDL-C (mg/dL) and elevated triglycerides (mg/dL). [ Time Frame: Change from baseline to 8 weeks in glucose tolerance ]
    Glucose tolerance: Proportion of individuals with normal glucose tolerance or prediabetes by the oral glucose tolerance test (OGTT) criteria.


Secondary Outcome Measures :
  1. Change from baseline in insulin sensitivity in two groups, those with elevated LDL-C (mg/dL) versus those with elevated LDL-C (mg/dL) and elevated triglycerides (mg/dL). [ Time Frame: Change from baseline to 8 weeks in insulin sensitivity ]
    Insulin Sensitivity: Steady-state plasma glucose concentration (mg/dL) measured during the insulin sensitivity test.

  2. Change from Baseline in insulin secretion in two groups, those with elevated LDL-C (mg/dL) versus those with elevated LDL-C (mg/dL) and elevated triglycerides (mg/dL). [ Time Frame: Change from baseline to 8 weeks in insulin secretion. ]
    Insulin Secretion: AUC-Insulin/AUC-Glucose defined as the ratio of the total area-under-the-insulin-curve (µU/mL·3hr) to the total area-under-the-glucose-curve (mg/dL·3hr) measured during the OGTT.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437084


Contacts
Contact: Cindy Lamendola, MSN, NP 650-723-3141 cindylam@stanford.edu
Contact: Fahim Abbasi, M.D. 650-724-0954 fahim@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Josh Knowles, M.D. Ph. D. Stanford University

Responsible Party: Joshua Knowles, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02437084     History of Changes
Other Study ID Numbers: STANFORD
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Insulin Resistance
Hyperlipidemias
Hyperlipoproteinemias
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors