The Effects of Anti-Inflammatory Treatment on Insulin Resistance in Healthy Volunteers
Condition: Type 2 Diabetes; Diabetes
MeSH terms: Diabetes Mellitus; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine
      whether reducing subclinical inflammation lessens insulin resistance in healthy, obese
      volunteers. The study findings may lead to new strategies for preventing type 2 diabetes. In
      diabetes, blood sugar is higher than normal and can result in serious medical problems, such
      as blindness and kidney failure. People with subclinical inflammation-inflammation that does
      not produce symptoms, such as fever, pain, or skin redness-are at increased risk for
      diabetes. Although the reasons for this are not completely understood, it is known that
      subclinical inflammation exacerbates insulin resistance, which is a cause of diabetes.
      Insulin is a hormone that helps control blood sugar, and when it does not work properly, the
      condition is known as insulin resistance.

      Normal, healthy volunteers between 18 and 45 years old with a body mass index of at least 30
      kg/m2 and who have subclinical inflammation (determined by blood tests) may be eligible for
      this study. Candidates must be non-smokers and must not have an alcohol or drug problem.
      Candidates will be screened with a medical history and physical examination,
      electrocardiogram, and blood and urine tests. Participants will maintain a standard diet and
      undergo tests and procedures during a 14-day inpatient stay at the Phoenix Indian Medical
      Center.
    

Detailed description: 
      In healthy subjects, low-grade inflammation, as measured by serum levels of cytokines or
      acute phase proteins, is positively associated with adiposity. Recent studies indicate that
      chronic low-grade inflammation in non-diabetic individuals may cause decline in insulin
      sensitivity and increases the risk of developing type 2 diabetes. It has been proposed that
      reduction of low-grade inflammation may reduce the risk of development of type 2 diabetes. In
      agreement with this hypothesis, the class of anti-inflammatory drugs called salicylates (such
      as aspirin) that influence a specific anti-inflammatory pathway have been found to decrease
      plasma glucose levels and increase insulin sensitivity in rodents as well as people with type
      2 diabetes.

      In the present study, we propose testing whether administration of the anti-inflammatory drug
      Salsalate improves insulin sensitivity in obese non-diabetic individuals and whether this
      improvement is related with a decrease in serum markers of inflammation. Subjects will be
      randomly assigned to two treatment groups: placebo or Salsalate (3g/d). An oral glucose
      tolerance test and a combined euglycemic/hyperglycemic clamp to assess insulin sensitivity
      and insulin secretion will be performed before and after seven days of treatment. Results of
      this study may help to identify novel strategies to prevent type 2 diabetes in high-risk
      groups.
    

Intervention name(s): Salsalate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention was salsalate (3g/day) for 7 days.; Identical placebo for 7 days.
Intervention MeSH terms: Salicylsalicylic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Salsalate; Insulin Resistance; Diabetes Mellitus; Inflammation; Diabetes; HCV