Diabetes type 2 , Life style vs Insulin. Alpril 5, 2019

Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin

by Diabetes Prevention Program Research Group


 February 7, 2002
N Engl J Med 2002; 346:393-403
DOI: 10.1056/NEJMoa012512
https://www.nejm.org/doi/full/10.1056/NEJMoa012512 

 We randomly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo, metformin (850 mg twice daily), or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week.

So, what is the goal of the study? What they pretend to find?

 Type 2 diabetes affects approximately 8 percent of adults in the United States. Some risk factors — elevated plasma glucose concentrations in the fasting state and after an oral glucose load, overweight, and a sedentary lifestyle — are potentially reversible. We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes.

WOW! Do you know how many members participated in investigations? Not less then hundred. I just do not want to copy that list.  But really, what was the subject of investigation? Money of cause. And for this reason diabetics type 2 best sheep supply.

The average follow-up was 2.8 years. The incidence of diabetes was 11.0, 7.8, and 4.8 cases per 100 person-years in the placebo, metformin, and lifestyle groups, respectively. The lifestyle intervention reduced the incidence by 58 percent (95 percent confidence interval, 48 to 66 percent) and metformin by 31 percent (95 percent confidence interval, 17 to 43 percent), as compared with placebo; the lifestyle intervention was significantly more effective than metformin.

I am sorry, it is still not the case that  life style intervention reversed diabetes or pre-diabetes, right? Regarding of any life style intervention and programs, diabetes was developed by 42% of participants, right? So, if we take Insulin in this stage of diabetes development, then what effect this therapy or intervention would have? 100% of all participants will be free from elevated blood sugar. No one incidence in diabetes development.
     Does anyone wish to prove this study? Ask investigators why insulin was not part of investigation. The answer is simple and obvious. As usual, investigators found all what they need, and never true.

Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk. The lifestyle intervention was more effective than metformin.

         More effective or less effective but still not preventive. Regardless of any intervention with Metformin or with life =style diabetes was developed withing 2.8 follow up year. Why it is 2.8 years, even not three years? That's right. The %%%% will be too high to present that life style intervention is number one treatment option. If investigation would be follow up 5 years, all participants would be in full bloom of diabetes type 2 development. If study would be follow up, by 10 years after study started all participants would gone. 
      What is most interesting in investigation? Authors are very careful to investigate how to avoid to find the true in investigation.  Look at the study.
 3234 nondiabetic persons.

 From 1996 to 1999, we randomly assigned 3234 study participants to one of the three interventions (1082 to placebo, 1073 to metformin, and 1079 to the intensive lifestyle intervention).

Eligibility criteri:

Eligibility criteria included
 an age of at least 25 years,
a body-mass index (the weight in kilograms divided by the square of the height in meters) of 24 or higher (22 or higher in Asians),
and a plasma glucose concentration of 95 to 125 mg per deciliter (5.3 to 6.9 mmol per liter) in the fasting state (≤125 mg per deciliter in the American Indian clinics)
and 140 to 199 mg per deciliter (7.8 to 11.0 mmol per liter) two hours after a 75-g oral glucose load. These concentrations are elevated but are not diagnostic of diabetes according to the 1997 criteria of the American Diabetes Association.
 Before June 1997, the criterion for plasma glucose in the fasting state was 100 to 139 mg per deciliter (5.6 to 7.7 mmol per liter), or ≤139 mg per deciliter in the American Indian clinics. 

       So, how all those participants were studied? I do understand that they all divided for groups. Some took metformin, other did not take it. It does not matter. What is important how investigation followed?

The blinded treatment phase was terminated one year early, in May 2001, on the advice of the data monitoring board, on the basis of data obtained through March 31, 2001, the closing date for this report. 

       It was only study, so why study were terminated? Because of too many participants developed diabetes, and diabetes development rushed in speedy way. No one of investigators wished to show the results of studies like that. What they suppose to show? That life style intervention lead to faster diabetes type 2 development? No one need this true. The goal is to show that life style intervention prevent diabetes development, and study show right opposit result. So, study were terminated, but result that 58% of those participants who were on life style modification, were published. This is why it is so odd that study follow up 2.8 years.

The participants were followed for an average of 2.8 years (range, 1.8 to 4.6). At the close of the study, 99.6 percent of the participants were alive, of whom 92.5 percent had attended a scheduled visit within the previous five months.

      Yes, they were alive 2.8 years follow up. Check up these participants 5 years follow up, 10 years follow up, and see how many of them still alive. Remember,. there were not diabetic yet, they were at risk of diabetes development, and as it is follow up from investigation, they developed diabetes  and gone of all cause of death withing 10 years after being at risk of diabetes development. Too sad statistic. This is why study must be terminated. They already got result how to keep Diabetes Life Stock in bay.

Our results support the hypothesis that type 2 diabetes can be prevented or delayed in persons at high risk for the disease. The incidence of diabetes was reduced by 58 percent with the lifestyle intervention and by 31 percent with metformin, as compared with placebo. These effects were similar in men and women and in all racial and ethnic groups.

There is no surprise in result when they are published.  But it is better to take a look at the studies, and see the results of the studies by your own eyes, no mental brain wash.

An estimated 10 million persons in the United States resemble the participants in the Diabetes Prevention Program in terms of age, body-mass index, and glucose concentrations, according to data from the third National Health and Nutrition Examination Survey.

       So, if we will have level of sugar as Vital, and then if blood sugar just elevated, regardless of level of elevation, treatment with insulin would be initiated, then diabetes type 2 development would be reduced by 100% . Try this study. Just start to study how non insulin diabetic react on right treatment, insulin therapy, and see, if it is life style intervention or right medicine safe human lives and reduce public medical spending.
     Where money, high money, $$$$$$ follow? In pockets of investigators with MD degree. To see the True, just follow money.

via Ravenvoron