But given that DE and ED are secondary endpoints for the trial, surely it's important simply for the question of psychological harm? If the trial is stopped early due to
DE in intervention group, we'll have a definitive answer as to the risks of VLED in kids
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Replying to @GidMK @BrownAdey and
I disagree with this stance. They are children. Not stats or lab rats. We don't have the right to put them at risk in the pursuit of knowledge.
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Replying to @HelenlouWest @BrownAdey and
But you've identified yourself that there's a lack of knowledge here. Without running a trial, we're guessing either way
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Replying to @GidMK @BrownAdey and
I don't think we are guessing. The objections come from what we know in adults + additional risks posed by growing kids - i'd say it's an evidence informed objection.
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Replying to @HelenlouWest @BrownAdey and
I'd argue that this study is dissimilar in that there is tight oversight of the included children which will hopefully minimize/obviate those risks
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Replying to @GidMK @HelenlouWest and
Also in terms of what we know in adults - I don't believe there were any risks identified in the DiRECT trial for DE/ED so would this be an issue? Not long term perhaps but certainly comparable in terms of intervention
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Replying to @GidMK @BrownAdey and
Feel like I’m repeating myself, but as shared earlier, ED/DE are u likely to be picked up in a study window and their effects are long standing and difficult to measure.
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Replying to @HelenlouWest @GidMK and
Let’s not forget, direct is an MNT with a goal of treating T2DM by targeting beta cell function. This study is targeting a background risk factor of ‘high weight’, In kids who don’t have a diagnosed disease for ‘prevention’.
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Replying to @HelenlouWest @BrownAdey and
That's fair, but I'd argue that the evidence for harms is not clear-cut and the study protocol seems robust to control for the remaining risk. I've never worked directly with the SCHN HREC but from what I hear they are extremely conservative so I imagine the controls are tight
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Replying to @GidMK @BrownAdey and
I disagree. There’s a reason why it’s mostly ED professionals objecting to this - we see the long term fall out of trying to fix ‘the weight’. I think we can do better for these kids.
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I guess the other side to that is that all of the endos I asked were very positive about the study because they see the long term fall out of not fixing 'the weight'. I'm not saying there's no risk, I'm just not convinced the cost/benefit is negative
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Replying to @sarahdempster @GidMK and
The animal data would suggest it’s safe and probably better than an excess calorie diet. Lots of work in mice and even some in primates.
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