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

A Clinical Study to Determine the Ability of Metamucil to Reduce Fasting Blood Glucose and HbA1c Levels in Type II NIDDM

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

Study Overview

• Status: Terminated
• Conditions: Non-Insulin-dependent Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: 3.4 g psyllium BID; Dietary supplement: 6.8g psyllium BID

Detailed Description

During the first phase, lead-in period during Subjects followed a diet judged to be within the acceptable guidelines of the ADA, with compliance assessed by a study dietician using 7-day food diaries completed by the patients. Subject body weight, serum glucose and serum HbA1c, and lipid levels were allowed to stabilize during this period.

During the 12-week treatment period, Subjects were stratified by either diet alone or diet and oral hypoglycemic medication and 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, patients 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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami, Diabetes Unit D-1
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; matched placebo BID	Dietary supplement: placebo; fiber-free placebo
Active Comparator: psyllium 3.4g BID; 3.4g psyllium BID for a Total of 6.8g daily	Dietary supplement: 3.4 g psyllium BID; 3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil); Other Names: Metamucil
Active Comparator: 6.8g psyllium BID; 6.8g psyllium BID for a total of 13.6 g/day	Dietary supplement: 6.8g psyllium BID; 6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil); Other Names: Metamucil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Glucose	Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value	12 weeks
Change From Baseline in Fasting HbA1c	Change is defined as Post-Baseline minus Baseline	12 weeks
Change From Baseline in Fasting HDL Cholesterol	Change is defined as Post-Baseline minus Baseline	12 weeks
Change From Baseline in Fasting LDL Cholesterol	Change is defined as Post-Baseline minus Baseline	12 weeks
Total Cholesterol Change From Baseline	Change is defined as Post-Baseline minus Baseline	12 weeks
Triglyceride Change From Baseline	Change is defined as Post-Baseline minus Baseline	12 weeks

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Principal Investigator: Michael Reeves, MD, University of Miami; Principal Investigator: Richard Bergenstal, MD, International Diabetes Center, Minneapolis, MN 55416

Study record dates

Study Major Dates

• Study Start: May 1, 1988
• Primary Completion (Actual): January 1, 1990
• Study Completion (Actual): January 1, 1990

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): November 15, 2012
• Last Update Submitted That Met QC Criteria: November 8, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Type II NIDDM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Gastrointestinal Agents; Cathartics; Antidiarrheals; Psyllium; Calcium polycarbophil
• Other Study ID Numbers: LX-105