Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects
Condition: Non-Insulin-dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: placebo; 3.4 g psyllium BID; 6.8g psyllium BID
Intervention description: fiber-free placebo; 3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil); 6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil)
Intervention MeSH terms: Psyllium; Calcium polycarbophil
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 36 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type II NIDDM

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a clinical diagnosis of Type II diabetes mellitus, controlled by diet and/or
             second generation oral hypoglycemic drugs, with the onset of the disease after age 35.

          -  Are between 0 and 50% above "normal" body weight (adjusted by frame) according to the
             Metropolitan Life Insurance Tables.

          -  Are male or female, aged 36-80 years with a diagnosis made at least 1 year prior to
             enrollment.

          -  Have an HbA1c level between 6 and 10%

          -  Have a fasting serum glucose level between 120-220 mg/dL and not vary by more than
             ±20% during the month prior to entering the treatment phase and HbA1c levels not vary
             by more than ±10% during the month prior to entering the treatment phase. Serum
             glucose level must have been between 120-220mg/dl and the subject's HbA1c between 6
             and 10% at Week 0.

          -  Have been on a "stable" diet consistent with ADA-recommended dietary guidelines with
             intake of total dietary fiber < 15g/1000 calories and were willing to maintain this
             diet during the 20-week study.

          -  Have maintained a constant body weight (±5%) during the month prior to entering the
             treatment phase

        Exclusion Criteria:

          -  Have a condition that would interfere with evaluation