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Experimental Studies of the Effects of Caffeine on Glucose Regulation

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
caffeine administration
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring caffeine, coffee, glucose, insulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 6 months or longer history of type 2 diabetes
  • treatment by diet, exercise, or oral medication
  • current daily consumption of 2 or more cups of coffee
  • BMI >21kg/M2 and < 45kg/M2

Exclusion criteria:

  • Required use of insulin
  • Current cigarette smoking
  • Current use of medications that impact glucose metabolism
  • Pregnancy
  • Other major medical disorders

Sites / Locations

    Outcomes

    Primary Outcome Measures

    postprandial glucose and insulin
    fasting glucose and insulin
    insulin resistance
    glucose tolerance

    Secondary Outcome Measures

    epinephrine
    norepinephrine
    cortisol
    blood pressure
    plasma caffeine concentration

    Full Information

    First Posted
    February 5, 2007
    Last Updated
    March 1, 2010
    Sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00432887
    Brief Title
    Experimental Studies of the Effects of Caffeine on Glucose Regulation
    Official Title
    Caffeine and Glucose Regulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2007 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    5. Study Description

    Brief Summary
    This project contains experimental studies of the effects of the drug caffeine on glucose regulation in adults who have Type 2 diabetes. In our experiments, we are testing the hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and insulin observed after meals in patients with type 2 diabetes. On separate study days subjects receive standard meals after taking capsules containing either caffeine or an inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood samples drawn over the next 3 hours. In a separate study, we use continuous glucose monitoring to measure glucose levels during everyday activities on days when subjects receive caffeine or placebo. These studies do not involve clinical treatment or disease management. However, we hope to learn whether a very popular drug impairs the clinical management of a common disease.
    Detailed Description
    Pilot results suggest that caffeine, the most commonly used drug in the world, may interfere with postprandial glucose metabolism by increasing insulin resistance and/or by stimulating hepatic glucose production. This effect could have serious clinical implications for coffee drinkers who have type 2 diabetes. Early results suggest caffeine exaggerates the postprandial hyperglycemia and hyperinsulinemia present in these patients. The experimental (non-treatment) studies in this project include double-blind placebo-controlled cross-over laboratory tests of glucose tolerance in groups of type 2 diabetic patients and prediabetic volunteers who are coffee drinkers. The lab studies test the hypothesis that caffeine (vs. placebo) increases postprandial insulin responses and results in a potentiation of glucose responses in the type 2 group. An ambulatory study examines the effects of caffeine administration on glucose levels during everyday activities in the natural environment. This study uses a double-blind placebo-controlled cross-over design. Ambulatory glucose data are collected with a MiniMed CGMS sensor and recorder worn for 72 hours. Caffeine and placebo are administered on separate days. Average glucose levels and glucose responses to meals are compared across treatment days within subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    caffeine, coffee, glucose, insulin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    150 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    caffeine administration
    Primary Outcome Measure Information:
    Title
    postprandial glucose and insulin
    Title
    fasting glucose and insulin
    Title
    insulin resistance
    Title
    glucose tolerance
    Secondary Outcome Measure Information:
    Title
    epinephrine
    Title
    norepinephrine
    Title
    cortisol
    Title
    blood pressure
    Title
    plasma caffeine concentration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: 6 months or longer history of type 2 diabetes treatment by diet, exercise, or oral medication current daily consumption of 2 or more cups of coffee BMI >21kg/M2 and < 45kg/M2 Exclusion criteria: Required use of insulin Current cigarette smoking Current use of medications that impact glucose metabolism Pregnancy Other major medical disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James D. Lane, Ph.D.
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Experimental Studies of the Effects of Caffeine on Glucose Regulation

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