Patients in the study also lowered their body mass index (BMI), waist and hip circumference, and fasting glucose levels, while improving their HDL-cholesterol and triglycerides. The results were reported at the American Diabetes Association's 72nd Scientific Sessions®.
"In light of the number of people with type 2 diabetes related to obesity, it's very important to investigate and explore any new tool that may have a positive effect on both weight and blood sugar," said Stephan Martin, MD, medical director of the West-German Diabetes and Health Centre in Düsseldorf, Germany, who conducted the study. "One of the most interesting findings to us was that Almased's positive effect on blood sugar was independent of its effect on weight loss."
Significant changes were seen at 12 weeks in the various study outcomes measured:
- Average insulin dose decreased from 147 to 65 units per day (p<0.0001).
- Weight decreased an average of 23 pounds (9%, p<0.0001).
- Average HbA1c, which is an overall measure of how well blood sugar is controlled, decreased from 8.8% to 8.1% (p=0.048).
- Fasting glucose, which is a measure of blood sugar after an eight-hour fast, decreased an average of 27.6 mg/dL (p=0.027).
- BMI decreased an average of 2.6 kg/m2 (p<0.0001).
- Average waist and hip circumferences decreased 2.8 inches (p=0.0003) and 1.3 inches (p=0.035), respectively.
- Triglycerides decreased an average of 70.3 mg/dL (p=0.0001) while HDL-cholesterol increased 2.2 mg/dL (p=0.049).
While the formal study with Almased ended after 12 weeks, investigators followed up with patients after one and a half years. Four patients who continued to use Almased reported additional decreases in insulin doses, HbA1c, and weight. Two of these patients were able to stop insulin injections completely. The long-term use among some patients points to the ease of incorporating Almased into a daily dietary routine suitable for people with type 2 diabetes. A larger study of more than 300 patients is underway in Germany to confirm the findings of this pilot study. Both of these studies are sponsored by Almased-Wellness-GmbH.
"Some people will be surprised that patients could stop insulin completely; we need to change the thinking that once insulin is started there is no way to stop it," said Dr. Martin. "Motivated patients who are committed to long-term dietary changes and increased physical activity can make a real change in their weight and metabolic measures."
"The problem of obesity and type 2 diabetes is large and growing," said Silke Ullmann, MPH, RD, LDN, of Almased USA. "We are committed to studying Almased to see how it may help people lose weight and gain better control of blood sugar levels."