Insulin Detemir in Obesity Management

What Was Tested

The trial (not phased) is built around Insulin Detemir.

The purpose of this study is to evaluate the effects of the medication insulin detemir on weight, brain function and mood, and on blood vessel and other risk factors for heart disease.

The study will compare how diet and insulin detemir affect areas of the brain that are involved in food intake and the sense of pleasure people get from eating.

Participants will be randomized into one of 2 groups.

It had two arms (groups): Insulin Detemir Treatment (experimental) and Comparator: No insulin (no intervention).

The registry classes the interventions as drug.

More on the Plan

Together with obesity, diabetes is epidemic in the US (20) and worldwide (21).

Weight gain can worsen insulin resistance leading to higher insulin requirements, and, thus perpetuates a vicious cycle (36), the ultimate effect of which may be to further enhance metabolic risk (15, 35).

Thus, while glycemic control is clearly a critical metabolic target in diabetes outcomes, additional considerations, including body weight (adiposity) and weight gain, are of fundamental importance in the clinical management of a complex disease such as diabetes.

In contrast to ample evidence associating insulin therapy with weight gain, a distinct body of evidence indicates that insulin functions as an adiposity negative feedback signal to the brain (23) and limits food intake and weight gain.

Who Took Part

The registry lists 240 planned participants were the target.

It was open to people of any sex aged from 31 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before any trial-related activities. Age at study entry is between 31-60 years of age. Body Mass index (BMI) between 30-49 kg/m2 using measured height and weight. Body weight \<350lbs (MRI table limit). Stable body weight during the previous 3 months with a less than 5 pounds self -reported weight change.

The full record lists 10 inclusion and 21 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study drug (insulin detemir); history of substance abuse, including but not exclusive to alcohol, cocaine, marijuana, heroin, nicotine; any tobacco use in last 3 months.

How the Study Was Run

Design: randomized, single-group and open-label.

Because people in this Insulin Detemir study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Being open-label, the Insulin Detemir study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-04 with completion listed for 2028-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 1 secondary outcome, for example Neuropsychiatric functions.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Detemir in 240 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Detemir compound page, all human trials.