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

NCT ID: NCT01582282

Last Updated: 2012-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1988-05-31
• Study Completion Date: 1990-01-31

Brief 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

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.

Conditions

Non-Insulin-dependent Diabetes Mellitus

Keywords

Type II NIDDM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

placebo

matched placebo BID

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

fiber-free placebo

psyllium 3.4g BID

3.4g psyllium BID for a Total of 6.8g daily

Group Type: ACTIVE_COMPARATOR

3.4 g psyllium BID

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: ACTIVE_COMPARATOR

6.8g psyllium BID

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

placebo

fiber-free placebo

Intervention Type: DIETARY_SUPPLEMENT

3.4 g psyllium BID

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

Intervention Type: DIETARY_SUPPLEMENT

6.8g psyllium BID

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Metamucil; Metamucil

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

• Minimum Eligible Age: 36 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Reeves, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Richard Bergenstal, MD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center, Minneapolis, MN 55416

Locations

University of Miami, Diabetes Unit D-1

Miami, Florida, United States

International Diabetes Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

LX-105

Identifier Type: -

Identifier Source: org_study_id