Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Non-Insulin-dependent Diabetes Mellitus
In brief
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
Key facts
- Study ID
- NCT01582282
- Run by
- Procter and Gamble
- People needed
- 37
- Starts
- 1988-05-01
- Expected to finish
- 1990-01-01
- Last updated by the study team
- 2012-11-15
Who can join
Age: 36 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Have a condition that would interfere with evaluation
Where it is running
- University of Miami, Diabetes Unit D-1 — Miami, Florida, United States
- International Diabetes Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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