Идёт набор NCT06925997

Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery

Ранняя фаза I С лечением Bariatric Surgery Candidate Bile Acid, Elevated Serum Glucose Metabolism Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Colesevelam.
Кому может быть актуально: Состояния в реестре: Bariatric Surgery Candidate, Bile Acid, Elevated Serum, Glucose Metabolism Disorders. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).

Подробное описание

The study design consists of 4 study visits, two performed before (V1 at day -7 and V2 at day 0 relative to initiation colesevelam treatment) and two after approximately 8 weeks of colesevelam treatment (V3 at day 49 and V4 at day 56). Biometrics, fasting blood samples and a standard mixed meal test are performed at V2 and V4. 75Se-HCAT scintigraphy is carried out between V1 to V2 and V3 to V4, respectively. Between V2 and V3 the subjects will have two telephone calls and one visit at the Endocrine Research Unit for fasting blood samples to make sure they do not experience any adverse events and are compliant.

The control groups will only participate in V1 and V2. The aim with the control groups is to have baseline values for unoperated subjects with and without diabetes to compare with the values in the intervention group after 8 weeks of depletion of endogenous bile acids.

Вмешательства

Препарат Colesevelam
Colesevelam is an approved drug with well known adverse events. Gastrointestinal side effects (Obstipation, flatulence, abdominal pain, diarrhea, nausea, meteorism, vomiting, chanced faeces) are very common (\>10%) or common (1-10%), but are mild and tolerable in most cases. All participants will be monitored closely, and colesevelam will be discontinued if the subject experience unreserved adverse events. All effects of colesevelam are transient (17-19) as the compound is not absorbed to the sy

Первичные конечные точки

Glucose [Срок оценки: 8 weeks]
FGF-19 [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

Intervention group

RYGB-operated ≥ 18 months prior to inclusion
History of diabetes prior to RYGB (HbA1c ≥48 mmol/mol or use of antidiabetic medication)
HbA1c <58 mmol/mol on no antidiabetic medication or metformin alone
Weight change < ±3 kg for >3 months at time of inclusion

Control group A

No history of diabetes
HbA1c <48 mmol/mol at time of inclusion
Fasting plasma glucose < 7.0 mmol/L at time of inclusion
Weight change < ±3 kg for >3 months at time of inclusion Control group B
Type 2 diabetes (HbA1c ≥48 mmol/mol or use of antidiabetic medication at time of inclusion)
Weight change < ±3 kg for >3 months at time of inclusion