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Gastrointestinal Hormonal Regulation of Obesity

10 mars 2021 mis à jour par: VA Office of Research and Development
The objective of this study is to test and determine whether a high protein diet is efficacious, safe and beneficial to curtail food intake and body weight in obese adult human patients and to establish whether neurohormonal mechanisms of a high protein diet induce an early signal of fullness or satiety in a relevant experimental model, focusing on activation of gastric vagal afferents.

Aperçu de l'étude

Description détaillée

Obesity is a major cause of morbidity and mortality within the VA medical system accounting for the majority of cases of diabetes mellitus, hypertension, coronary artery disease and cerebrovascular accidents. An improved understanding of the regulation of body weight in Veteran obese patients will improve the quality of life by avoidance of serious medical complications and by suggesting novel therapeutic approaches.

The large proportion of the Veteran population that frequent the VA health care system and who suffer from obesity or have obesity-related illnesses can benefit from this research.

Obesity is associated with early mortality in the United States. It has been estimated to result in about 280,000 deaths per year in U.S. adults and the expenses related to obesity are in excess of $80 billion. Obesity is a major cause of morbidity and mortality within the VA medical system accounting for the majority of cases of diabetes mellitus, hypertension, coronary artery disease and cerebrovascular accidents.

The proposed studies will address important physiological questions regarding the mechanisms of gut peptides regulating satiety and food intake, as well as provide potentially important clinical treatment strategies. The release of GI hormones in response to meal stimuli plays an important role in the regulation of body weight homeostasis. The neural pathways interconnecting gut signaling of satiety to the brain in response to nutrient intake are regulated by neuropeptides and GI hormones.

The investigators have a long history in the study of GI hormones. In the current application, the investigators plan to elucidate the impact of a high protein diet on the profile of gut hormones released postprandially in obese subjects and the underlying changes at the neuronal (vagal afferent) level that take place in response to a high protein diet in a relevant experimental model.

Understanding the regulatory mechanisms involved in satiety will provide clues for existing and novel forms of therapies. Studies may also provide insight into underlying mechanisms responsible for weight loss induced by gastroplasty and bariatric procedure used for the treatment of obesity.

The study design is a three-group randomized, controlled study. This randomized controlled study lasting 24-30 months will assign approximately 198 volunteer subjects (ages 30, BMI 27-40 kg/m2) (66 subjects each) to the following three groups who will adhere to diets with the same number of calories:

  1. Very high protein diet group based on 1.4 gram of protein per pound of lean body mass,
  2. High protein diet group based on 1 gram of protein per pound of lean body mass, and
  3. Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories.

All participants will meet with a Registered Dietitian (who it is anticipated will join the research study team), to assist them with their diet efforts in all the arms.

In the study, the percent energy from fat will be held constant at 30% and the differences in the diets relate only to the protein and carbohydrate contents (35% protein and 35% carbohydrate, 25% protein and 45% carbohydrate, and 12.5% protein and 57.5% carbohydrate respectively).

We will assess the efficacy of a high protein diet on satiety and pattern of postprandial gut hormone in obese patients. All the subjects will be followed by a dietitian and determination of circulating gut hormone and biochemical assays will be performed.

Type d'étude

Interventionnel

Inscription (Réel)

31

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • California
      • West Los Angeles, California, États-Unis, 90073
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

For inclusion in the study, patients must fulfill all of the following criteria:

  • Subjects must be able to attend all 7 scheduled study visits at the West LA GI clinic at the VAGLAHS, not including the screening visit.
  • Subjects must sign the VA Greater Los Angeles Healthcare System Institutional Review Board approved written informed consent prior to the initiation of any study-related activities or study specific procedures or randomization.
  • Subjects must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.

After the Informed Consent process, these additional Inclusion Criteria will be applied to potential subjects:

  • Age 30 years and older at screening.
  • BMI of 27 to 40 kg/m2 inclusive.
  • Subjects must be in good health as determined by medical history, physical examination performed by the Investigator (Study doctor) at the Screening stage, and screening clinical laboratory tests including chemistry panel and CBC.
  • Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
  • Subjects requiring the regular use of any prescription medication may be admitted to the study, providing the dose is stable.
  • Subjects must be able to communicate and cooperate with the Principal Investigator and the staff and willing to comply with the study instructions.

Exclusion Criteria:

  • Weight instability: Subjects reporting weight change of greater than 3.0 kg in the month prior to screening.
  • Any subject who has been on a very low calorie diet (less than 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost greater than 10 kg in the 6 months prior to screening.
  • Any subject who has a history of diabetic gastroparesis or gastric emptying disorder as indicated in the potential subject's medical history and VA's Computer Patient Record System (CPRS).
  • Use of any other investigational drug(s) within 8 weeks prior to screening.
  • Subjects should not have received antibiotics within the prior 4 weeks of screening.
  • Abnormal laboratory parameters:
  • Serum creatinine greater than 1.6 mg/dL;
  • Liver function tests, alanine transaminase (ALT), alanine transaminase (AST), Bilirubin results greater than 2.0 times the upper limit of normal;
  • Triglycerides greater than 500 mg/dL;
  • Total cholesterol greater than 350 mg/dL;
  • Thyroid-stimulating hormone (TSH) outside of normal range disorder, as indicated in the potential subject's medical history, the VA's Computer Patient Record System (CPRS) and laboratory tests performed during the screening process.
  • Subjects who drink more than 1 alcoholic beverage per day (that is: 1 beer; or 1 glass of wine; or 1 shot of liquor).
  • Pregnant women or women likely to become pregnant during the course of the study may not participate in this study. Female subjects must not be able to conceive by reason of surgery, radiation, one year past the onset of menopause, or an approved method of contraception.
  • No vulnerable subjects will be included in the study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Régime standard
Groupe de régime protéiné standard comme contrôle basé sur 0,5 gramme de protéines par livre de masse corporelle maigre avec les mêmes calories : 15 % de protéines et 55 % de glucides.
Régime protéiné standard comme témoin, basé sur 0,5 gramme de protéines par livre de masse corporelle maigre, isocalorique (même nombre de calories) et composé de 15 % de protéines et de 55 % de glucides.
Autres noms:
  • Régime protéiné standard
Comparateur actif: Régime riche en protéines
Groupe de régime riche en protéines basé sur 1 gramme de protéines par livre de masse corporelle maigre : 30 % de protéines et 40 % de glucides.
Régime riche en protéines, basé sur 1 gramme de protéines par livre de masse corporelle maigre du sujet, isocalorique (même nombre de calories) et composé de 30 % de protéines et de 40 % de glucides.
Autres noms:
  • Régime riche en protéines

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Body Weight From Baseline to 12 Months
Délai: The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.
The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard diet.
The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Efficacy Variables: Nutrition Assessments (FFQ, 3DFR, and Satiety Questionnaire), Anthropometric Profiles (e.g., Waist and Hip Circumferences), Lab and Biochemical Variables (e.g., Insulin, Lipid Levels, HbA1c), Body Composition (Body Fat), Hormone Level
Délai: The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject.
High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity
The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject.
Safety Variables: Incidence, Severity and Duration of Adverse Events, Vital Signs, Concomitant Medications and Physical Examination Results.
Délai: Safety variables are measured at the time any adverse events occur, and vital signs, concomitant medications and physical examination results are measured at Baseline on Day 1 and monthly throughout the 12 month study period for each subject.
High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity
Safety variables are measured at the time any adverse events occur, and vital signs, concomitant medications and physical examination results are measured at Baseline on Day 1 and monthly throughout the 12 month study period for each subject.
Improvement in NAFLD Fibrosis Score
Délai: 1 year
Patients enrolled with a history of NAFLD will be assessed for improvement in NAFLD Fibrosis scoring index and other imaging parameters if performed as standard clinical care.
1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Joseph R Pisegna, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2010

Achèvement primaire (Réel)

31 décembre 2018

Achèvement de l'étude (Réel)

27 février 2019

Dates d'inscription aux études

Première soumission

2 avril 2010

Première soumission répondant aux critères de contrôle qualité

16 juin 2010

Première publication (Estimation)

17 juin 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 avril 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 mars 2021

Dernière vérification

1 mars 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • F7219-R

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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