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

This study has been terminated.
(due to slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT01582282
First received: April 18, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Non-Insulin-dependent Diabetes Mellitus
Dietary Supplement: placebo
Dietary Supplement: 3.4 g psyllium BID
Dietary Supplement: 6.8g psyllium BID
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Clinical Study to Determine the Ability of Metamucil to Reduce Fasting Blood Glucose and HbA1c Levels in Type II NIDDM

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Change From Baseline in Fasting Glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value

  • Change From Baseline in Fasting HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change is defined as Post-Baseline minus Baseline

  • Change From Baseline in Fasting HDL Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change is defined as Post-Baseline minus Baseline

  • Change From Baseline in Fasting LDL Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change is defined as Post-Baseline minus Baseline

  • Total Cholesterol Change From Baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change is defined as Post-Baseline minus Baseline

  • Triglyceride Change From Baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change is defined as Post-Baseline minus Baseline


Enrollment: 37
Study Start Date: May 1988
Study Completion Date: January 1990
Primary Completion Date: January 1990 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
matched placebo BID
Dietary Supplement: placebo
fiber-free placebo
Other Name: 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 Name: 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 Name: Metamucil

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.

  Eligibility

Ages Eligible for Study:   36 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582282

Locations
United States, Florida
University of Miami, Diabetes Unit D-1
Miami, Florida, United States, 33136
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Procter and Gamble
Investigators
Principal Investigator: Michael Reeves, MD University of Miami
Principal Investigator: Richard Bergenstal, MD International Diabetes Center, Minneapolis, MN 55416
  More Information

No publications provided

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT01582282     History of Changes
Other Study ID Numbers: LX-105
Study First Received: April 18, 2012
Results First Received: October 3, 2012
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Procter and Gamble:
Type II NIDDM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antidiarrheals

ClinicalTrials.gov processed this record on April 22, 2014