Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?

NCT ID: NCT02007577

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-11-30

Brief Summary

The possibility that obesity-associated inflammatory changes may play a role in the pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that salicylates might represent a useful treatment to improve glucose tolerance. Several studies, performed in patients with 2DM, as well as in nondiabetic, obese individuals, have demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but have not led to a coherent view as to the mechanism(s) involved.

In this research proposal we will use specific methods to quantify insulin mediated glucose uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers to identify those individuals who are sufficiently insulin resistant to be enrolled in this study. We will then use the graded glucose infusion technique in these insulin resistant subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline measurements, salsalate or placebo will be administered for one month to the participants, after which time the IST and the graded glucose infusion will be repeated to quantify and compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus placebo. These results will provide for the first time quantitative data of the effect of salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic individuals.

Conditions

Pre Diabetes; Insulin Resistant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

salsalate 3500mg in 2 divided doses a day

Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner

Group Type: ACTIVE_COMPARATOR

salsalate

Intervention Type: DRUG

Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner

placebo

Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will take 3 tablets with breakfast and 4 tablets with dinner

Interventions

salsalate

Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner

Intervention Type: DRUG

Placebo

Participants will take 3 tablets with breakfast and 4 tablets with dinner

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers,
• BMI 25-35kg/m2,
• Without severe anemia, kidney, liver disease or any current GI ulcers or bleeding
• Or on any medication contraindicated with salsalate

Exclusion Criteria

• Recent history of GI bleed or ulcers,
• CVD or on anticoagulants
• Severe kidney or liver disease
• Allergies to aspirin
• Taking aspirin or anti inflammatory medication on a regular basis and cannot be taken off for the duration of the study

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Gerald M Reaven

Professor Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald M Reaven, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Kim SH, Liu A, Ariel D, Abbasi F, Lamendola C, Grove K, Tomasso V, Ochoa H, Reaven G. Effect of salsalate on insulin action, secretion, and clearance in nondiabetic, insulin-resistant individuals: a randomized, placebo-controlled study. Diabetes Care. 2014 Jul;37(7):1944-50. doi: 10.2337/dc13-2977.

Reference Type: DERIVED

PMID: 24963111 (View on PubMed)

Other Identifiers

19254

Identifier Type: -

Identifier Source: org_study_id