ID

18574

Beschreibung

Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00207233

Link

https://clinicaltrials.gov/show/NCT00207233

Stichworte

Versionen (1)
  1. 11.11.16 11.11.16 -
Hochgeladen am

11. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Obesity NCT00207233

Englisch

Eligibility Obesity NCT00207233

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00207233
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient of the nutrition and weight management center at boston medical center
Beschreibung

Patient Medical center Body Weight

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0565990
UMLS CUI [1,3]
C0005910
obese ( bmi equal or greater to 30 kg/m2
Beschreibung

Obesity | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C0028754
UMLS CUI [2]
C1305855
men and women
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
age more than or equal to 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes mellitus controlled by diet or use of metformin or impaired fasting glucose (fbs more than or equal to 100 mg/dl)
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Dietary control | Metformin | Impaired fasting glycaemia | Fasting Blood Sugar Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0743195
UMLS CUI [3]
C0025598
UMLS CUI [4]
C1272092
UMLS CUI [5]
C2825162
only diet-controlled diabetics or those on metformin will be considered since all classes of anti-diabetic agents have different effects on appetite and body weight, which may confound the interpretation of study results.
Beschreibung

Diabetic Dietary control | Metformin | Antidiabetics Interfere research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241863
UMLS CUI [1,2]
C0743195
UMLS CUI [2]
C0025598
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently not a patient at the nutrition and weight management center at boston medical center
Beschreibung

Patient Medical center Body Weight

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0565990
UMLS CUI [1,3]
C0005910
need for oral anti-diabetic agents (other than metformin)
Beschreibung

Antidiabetics Oral Patient need for | Metformin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C0025598
abnormal thyroid status: hyperthyroidism or hypothyroidism (tsh less than 0.5 or more than 5.0)
Beschreibung

thyroid function Abnormal | Hyperthyroidism | Hypothyroidism | Thyroid stimulating hormone measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2242456
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0020676
UMLS CUI [4]
C0202230
significant liver disease (bilirubin more than or equal to 2.0 or liver enzyme more than 3 times upper limited of normal range)
Beschreibung

Liver disease Significant | Serum total bilirubin measurement | Measurement of liver enzyme

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0428321
significant renal disease (creatinine more than or equal to 2.0)
Beschreibung

Kidney Disease Significant | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0201976
on the following medications known to affect carbohydrate and lipid metabolism: steroids, beta adrenergic blockers, diuretics, insulin, and hypolipidemic agents
Beschreibung

Pharmaceutical Preparations Affecting Carbohydrate Metabolism | Pharmaceutical Preparations Affecting Lipid Metabolism | Steroids | Adrenergic beta-Antagonists | Diuretics | Insulin | Hypolipidemic Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0302820
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0598783
UMLS CUI [3]
C0038317
UMLS CUI [4]
C0001645
UMLS CUI [5]
C0012798
UMLS CUI [6]
C0021641
UMLS CUI [7]
C0086440
use of prescription or over the counter weight loss medications
Beschreibung

Weight-Loss Agents prescribed | Weight-Loss Agents Non-Prescription

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C0278329
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
weight loss of >5% or more in the last three (3) months
Beschreibung

Percentage weight loss

Datentyp

boolean

Alias
UMLS CUI [1]
C0424661
anorexia nervosa or bulimia nervosa
Beschreibung

Anorexia Nervosa | Bulimia Nervosa

Datentyp

boolean

Alias
UMLS CUI [1]
C0003125
UMLS CUI [2]
C2267227
pregnancy or lactation
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant lactose intolerance
Beschreibung

Lactose Intolerance Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022951
UMLS CUI [1,2]
C0750502
significant egg allergy
Beschreibung

Allergy to eggs Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0559469
UMLS CUI [1,2]
C0750502
history of drug or alcohol addiction.
Beschreibung

Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
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Ähnliche Modelle

Eligibility Obesity NCT00207233

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00207233
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Patient Medical center Body Weight
Item
patient of the nutrition and weight management center at boston medical center
boolean
C0030705 (UMLS CUI [1,1])
C0565990 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
Obesity | Body mass index
Item
obese ( bmi equal or greater to 30 kg/m2
boolean
C0028754 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Gender
Item
men and women
boolean
C0079399 (UMLS CUI [1])
Age
Item
age more than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Dietary control | Metformin | Impaired fasting glycaemia | Fasting Blood Sugar Measurement
Item
type 2 diabetes mellitus controlled by diet or use of metformin or impaired fasting glucose (fbs more than or equal to 100 mg/dl)
boolean
C0011860 (UMLS CUI [1])
C0743195 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1272092 (UMLS CUI [4])
C2825162 (UMLS CUI [5])
Diabetic Dietary control | Metformin | Antidiabetics Interfere research results
Item
only diet-controlled diabetics or those on metformin will be considered since all classes of anti-diabetic agents have different effects on appetite and body weight, which may confound the interpretation of study results.
boolean
C0241863 (UMLS CUI [1,1])
C0743195 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Patient Medical center Body Weight
Item
currently not a patient at the nutrition and weight management center at boston medical center
boolean
C0030705 (UMLS CUI [1,1])
C0565990 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
Antidiabetics Oral Patient need for | Metformin
Item
need for oral anti-diabetic agents (other than metformin)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
thyroid function Abnormal | Hyperthyroidism | Hypothyroidism | Thyroid stimulating hormone measurement
Item
abnormal thyroid status: hyperthyroidism or hypothyroidism (tsh less than 0.5 or more than 5.0)
boolean
C2242456 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0020550 (UMLS CUI [2])
C0020676 (UMLS CUI [3])
C0202230 (UMLS CUI [4])
Liver disease Significant | Serum total bilirubin measurement | Measurement of liver enzyme
Item
significant liver disease (bilirubin more than or equal to 2.0 or liver enzyme more than 3 times upper limited of normal range)
boolean
C0023895 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0428321 (UMLS CUI [3])
Kidney Disease Significant | Creatinine measurement, serum
Item
significant renal disease (creatinine more than or equal to 2.0)
boolean
C0022658 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Pharmaceutical Preparations Affecting Carbohydrate Metabolism | Pharmaceutical Preparations Affecting Lipid Metabolism | Steroids | Adrenergic beta-Antagonists | Diuretics | Insulin | Hypolipidemic Agents
Item
on the following medications known to affect carbohydrate and lipid metabolism: steroids, beta adrenergic blockers, diuretics, insulin, and hypolipidemic agents
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0302820 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0598783 (UMLS CUI [2,3])
C0038317 (UMLS CUI [3])
C0001645 (UMLS CUI [4])
C0012798 (UMLS CUI [5])
C0021641 (UMLS CUI [6])
C0086440 (UMLS CUI [7])
Weight-Loss Agents prescribed | Weight-Loss Agents Non-Prescription
Item
use of prescription or over the counter weight loss medications
boolean
C0376606 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
Percentage weight loss
Item
weight loss of >5% or more in the last three (3) months
boolean
C0424661 (UMLS CUI [1])
Anorexia Nervosa | Bulimia Nervosa
Item
anorexia nervosa or bulimia nervosa
boolean
C0003125 (UMLS CUI [1])
C2267227 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lactose Intolerance Significant
Item
significant lactose intolerance
boolean
C0022951 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Allergy to eggs Significant
Item
significant egg allergy
boolean
C0559469 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Substance Dependence
Item
history of drug or alcohol addiction.
boolean
C0038580 (UMLS CUI [1])
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