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Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects

NCT01582282 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-11-15

Study results available
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Summary

A double-blind, randomized, placebo-controlled, multi-dose clinical study consisting of 2 phases; 1) an 8-week lead-in period during which patients followed a diet judged to be within the acceptable guidelines of the ADA, and 2) a 12-week treatment period, at the beginning of which, Subjects are randomly assigned to 1 of the 3 treatment groups: placebo, 3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil) or 6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil). For 12 weeks, Subjects took Metamucil or the fiber-free placebo BID, just prior to breakfast and dinner.

Patients visited the clinic 10 times during the 20-week period at Screening, Weeks -8, -6, -4, 0, Day 3, and Weeks 2, 4, 8 and 12, fasting at least 12 hours prior to each visit where a blood sample was taken (all visits except Week -6 and Day 3) for analysis of fasting serum glucose and lipid levels, and HbA1c. Clinical chemistry, hematology and urinalysis were done at Weeks -8, 0 and 12. The completed 7-day food diaries were reviewed by the study dietician at each visit and discussed with the patient to ensure compliance with the recommended diet and the patients' body weights were recorded

Conditions

  • Non-Insulin-dependent Diabetes Mellitus

Interventions

DIETARY_SUPPLEMENT

placebo

fiber-free placebo

DIETARY_SUPPLEMENT

3.4 g psyllium BID

3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil)

DIETARY_SUPPLEMENT

6.8g psyllium BID

6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil)

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Michael Reeves, MD · University of Miami

  • Richard Bergenstal, MD · International Diabetes Center, Minneapolis, MN 55416

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
36 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1988-05-31
Primary Completion
1990-01-31
Completion
1990-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582282 on ClinicalTrials.gov