Clinical trial NCT01582282: Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects
Official title: A Clinical Study to Determine the Ability of Metamucil to Reduce Fasting Blood Glucose and HbA1c Levels in Type II NIDDM
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Non-Insulin-dependent Diabetes Mellitus
Keywords: Type II NIDDM
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 37
Sex: ALL
Minimum age (years): 36
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change From Baseline in Fasting Glucose
timeFrame: 12 weeks
measure: Change From Baseline in Fasting HbA1c
timeFrame: 12 weeks
measure: Change From Baseline in Fasting HDL Cholesterol
timeFrame: 12 weeks
measure: Change From Baseline in Fasting LDL Cholesterol
timeFrame: 12 weeks
measure: Total Cholesterol Change From Baseline
timeFrame: 12 weeks
measure: Triglyceride Change From Baseline
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, Diabetes Unit D-1
state: Florida
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: University of Miami
name: Michael Reeves, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center, Minneapolis, MN 55416
name: Richard Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
References: