Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers (INDIGO-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04076995
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Arizona State University

Tracking Information
First Submitted Date  ICMJE August 27, 2019
First Posted Date  ICMJE September 4, 2019
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE September 18, 2019
Estimated Primary Completion Date December 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
  • Area under the curve of Glucose at lunch [ Time Frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm) ]
  • Area under the curve of Glucose at Dinner [ Time Frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm) ]
  • Area under the curve of Glucose for the entire experiment [ Time Frame: 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm) ]
  • Area under the curve of Copeptin for the entire experiment [ Time Frame: 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm) ]
  • Area under the curve of Glucagon at lunch [ Time Frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm) ]
  • Area under the curve of Glucagon at dinner [ Time Frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm) ]
  • Urinary glucose excretion [ Time Frame: Entire 11-hour protocol 7:00 am - 6:00 pm ]
  • Area Under the Curve for Plasma osmolality [ Time Frame: the entire 11-hour protocol 7:00 am - 6:00 pm ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04076995 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
  • Area under the curve of Insulin at lunch [ Time Frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm) ]
  • Area under the curve of Insulin at dinner [ Time Frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm) ]
  • Area under the curve of Glucagon like peptide 1 at dinner [ Time Frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm) ]
  • Area under the curve of Glucagon like peptide 1at lunch [ Time Frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm) ]
  • Area under the curve of plasma cortisol [ Time Frame: the entire 11-hour protocol 7:00 am - 6:00 pm ]
  • Area under the curve for Thirst rating [ Time Frame: the entire 11-hour protocol 7:00 am - 6:00 pm ]
    Thirst assessed by Visual analog scale
  • Mood assessment with a questionnaire [ Time Frame: single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm ]
    Assessed by Profile of mood state questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
Official Title  ICMJE INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
Brief Summary Previous studies have indicated increased vasopressin due to hypertonic saline infusion impairs glucose regulation. The current study will examine the effect of low water intake on glucose regulation. No currently published study has investigated the acute effect of low water intake on glucose regulation using continuous glucose monitoring over the course of a full day. The aim of the study is to observe the effect of low water intake on glucose regulation in low drinkers. The study will study the glycemic responses to standardized meals in adults during an 11-hour period in two conditions: a) high water intake and b) low water intake. It is hypothesized that the area under the glucose curve will be greater in the low water intake trial as compared to the high water intake trial
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Dehydration
  • Diabetes Mellitus, Type 2
Intervention  ICMJE Other: Water Intake
Increased water intake during the 11 h protocol
Study Arms  ICMJE
  • Experimental: High Water intake
    High water intake of 3.0 L/day in males and 2.0 L/day in females
    Intervention: Other: Water Intake
  • Active Comparator: Low Water Intake
    Low water intake of 0.5 L/day in males and 0.4 L/day
    Intervention: Other: Water Intake
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2019)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date December 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy sedentary participants
  • aged 30-55 years
  • body mass 27.5-35.0 kg·m2
  • low water intake less than 1.5 L∙day-1 (male) or 1.0 L∙day-1 (female)
  • 24 h urine osmolality greater than 800 mmol/kg

Exclusion Criteria:

  • diabetes HbA1c >6.5%
  • impaired liver or kidney function
  • cardiovascular disease
  • weight change of more than 3 kg in the past month
  • pregnancy
  • previous surgery on digestive tract
  • exercise >4 h/week
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Adam Seal 479-531-6059 adam.seal@asu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04076995
Other Study ID Numbers  ICMJE STUDY00010276
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arizona State University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP