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

Non-Insulin-dependent Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01582282
• Other study ID #: LX-105
• Status: Terminated
• Phase: Phase 4
• First received: April 18, 2012
• Last updated: November 8, 2012
• Start date: May 1988
• Est. completion date: January 1990

Study information

• Verified date: November 2012
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: January 1990
• Est. primary completion date: January 1990
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Non-Insulin-dependent Diabetes Mellitus

Intervention

Dietary Supplement:
• placebo
fiber-free placebo
• 3.4 g psyllium BID
3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil)
• 6.8g psyllium BID
6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil)

Locations

Country	Name	City	State
United States	University of Miami, Diabetes Unit D-1	Miami	Florida
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Fasting Glucose	Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value	12 weeks	No
Primary	Change From Baseline in Fasting HbA1c	Change is defined as Post-Baseline minus Baseline	12 weeks	No
Primary	Change From Baseline in Fasting HDL Cholesterol	Change is defined as Post-Baseline minus Baseline	12 weeks	No
Primary	Change From Baseline in Fasting LDL Cholesterol	Change is defined as Post-Baseline minus Baseline	12 weeks	No
Primary	Total Cholesterol Change From Baseline	Change is defined as Post-Baseline minus Baseline	12 weeks	No
Primary	Triglyceride Change From Baseline	Change is defined as Post-Baseline minus Baseline	12 weeks	No