None listed
Conditions
Brief summary
Diabetes is one of the most pressing health issues in Fiji today. It is estimated that 40% of Fiji’s population suffer from type 2 diabetes. Several public health strategies have been used to address this issue but there has not been a significant change in the figures. Therefore, pharmacological intervention may be of value in curbing the problem. Medical literature suggests that early therapy with insulin and oral hypoglycaemic agents are of benefit in delaying complications of diabetes in newly diagnosed patients. On this note, this proposed study will focus on the effectiveness of insulin therapy and insulin/metformin combination therapy in individuals with impaired glucose tolerance and impaired fasting glucose. The study is based on the fact that impaired glucose tolerance to frank type2 diabetes is the progressive loss of insulin secretary capacity (functioning pancreatic beta cells). It is therefore, hypothesized that administration of insulin in patients at risk of developing diabetes will give time to the pancreatic beta cells to rest and regenerate. Animal studies have shown that high rate of glucose metabolism triggers beta cells to regenerate. The proposed study will be based in Suva and include 45 subjects having an impaired glucose tolerance or an impaired fasting glucose. 15 patients will be given a dose of long-acting insulin, 15 patients will be given a combination dose of long-acting insulin/metformin, while the other 15 will be the control group. Serum insulin, HbA1c, BMI and 2-hour oral glucose tolerance results will be recorded at regular intervals. The study will proceed for 3 months. The study also involves the checking of the results after 1 year since the beginning of the trial.
Interventions
1. Experimental
Intervention: Daily subcutaneous insulin isophane injection therapy with a dosage adjusted by 2unit/week increments to get Fasting capillary blood glucose 4-5.6 mmol / L as the goal for a duration of 3 months. The dose range is 5-10 units of insulin.
2. Experimental
Intervention: Daily oral metformin 500 mg twice a day as a fixed dose and subcutaneous insulin isophane injection therapy with a dosage adjusted by 2unit/week increments to get Fasting capillary blood glucose 4-5.6
1. Experimental Intervention: Daily subcutaneous insulin isophane injection therapy with a dosage adjusted by 2unit/week increments to get Fasting capillary blood glucose 4-5.6 mmol / L as the goal for a duration of 3 months. The dose range is 5-10 units of insulin. 2. Experimental Intervention: Daily oral metformin 500 mg twice a day as a fixed dose and subcutaneous insulin isophane injection therapy with a dosage adjusted by 2unit/week increments to get Fasting capillary blood glucose 4-5.6 mmol / L as the goal for a duration of 3 months. The dose range is 5-10 units of insulin. 3. Control Intervention: nil (standard lifestyle counseling).
Sponsors
Rishaal Sharma
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
21 years of age or older Not specific to any gender or ethnic groups; Persons with HbA1c between >= 5.7% and <6.5%; Persons with impaired glucose tolerance or impaired fasting glucose levels
Exclusion criteria
Known diabetes (Fasting Plasma Glucose > 7.0 mmol/l; 2-hour 75-g OGTT plasma glucose > 11.1 mmol/l; HbA1c result HbA1c<5.7% or > =6.5%; Diabetes diagnosed by a physician and confirmed by other clinical data; Self-reported hospitalization for treatment of heart disease in past 6 months; Impaired renal and liver function, and pancreatitis; Self-reported recent or significant abdominal surgery; Self-reported pregnancy and/or intentional pregnancy during the study; Self-reported hospitalization for stroke or transient ischemic attack episode in the past 6 months; Anemia; Inability to ensure availability for the next 12 months
Outcome results
None listed