ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    10896648 [PUBMED-IDS]

Effects of Progressive Negative Energy Balance on Glucose Tolerance, Insulin Sensitivity, and Beta-cell Function

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03264001
Recruitment Status : Active, not recruiting
First Posted : August 28, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Faidon Magkos, Clinical Nutrition Research Centre, Singapore

Brief Summary:

Type 2 diabetes results from a combination of peripheral insulin resistance and beta-cell dysfunction, and manifests as fasting and postprandial hyperglycemia. In Singapore, despite the relatively low prevalence of overweight and obesity, the prevalence of type 2 diabetes is disproportionately high and is expected to double in the near future. This indicates that insulin resistance and beta-cell dysfunction are widely prevalent even among individuals who are not overweight or obese. Still, weight loss induced by a variety of ways (calorie restriction, exercise, surgery, etc.) is considered the cornerstone of diabetes treatment. This underscores the importance of negative energy balance in improving metabolic function. In fact, negative energy balance induced by calorie restriction can improve metabolic function acutely, i.e. within 1-2 days and before any weight loss occurs. Likewise, negative energy balance induced by a single session of aerobic exercise improves metabolic function over the next few days. However, the magnitude of negative energy balance that needs to be achieved in order to improve metabolic function, as well as possible dose-response relationships, are not known. Furthermore, the comparative efficacy of calorie restriction vs. exercise in improving metabolic function has never been directly assessed.

Accordingly, a better understanding of the effects of acute negative energy balance induced by calorie restriction or aerobic exercise on insulin sensitivity and beta-cell function will have important implications for public health, by facilitating the design of effective lifestyle (diet and physical activity) interventions to prevent or treat type 2 diabetes.

To test these hypotheses, whole-body insulin sensitivity, the acute insulin response to glucose, and the disposition index (i.e. beta-cell function), will be determined the morning after a single day of progressively increasing negative energy balance (equivalent to 20% or 40% of total daily energy needs for weight maintenance) induced by calorie restriction or aerobic exercise.

Results from this project are expected to result in the better understanding of the effects of negative energy balance induced by diet and exercise on metabolic function. Therefore, this project may help in the design of effective lifestyle intervention programs for the prevention and treatment of type 2 diabetes.


Condition or disease Intervention/treatment Phase
Insulin Sensitivity Glucose Intolerance Insulin Resistance Energy Supply; Deficiency Behavioral: Negative energy balance Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Progressive Negative Energy Balance Induced by Diet or Exercise on Glucose Tolerance, Insulin Sensitivity, and Beta-cell Function
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diet-induced negative energy balance
For the diet-induced negative energy balance arm, the three trials will include one control trial (isocaloric diet; zero energy balance) and two trials of progressively increasing negative energy balance induced by calorie restriction (20% and 40% reduction of daily energy needs for weight maintenance). With respect to physical activity, all diet trials will be performed under resting conditions.
Behavioral: Negative energy balance
20% and 40% reduction of daily energy needs for weight maintenance
Experimental: Exercise-induced negative energy balance
For the exercise-induced negative energy balance arm, the three trials will include one control trial (rest; zero energy balance) and two trials of progressively increasing negative energy balance induced by aerobic exercise (20% and 40% reduction of daily energy needs for weight maintenance); with respect to caloric intake, all exercise trials will be performed under isocaloric conditions.
Behavioral: Negative energy balance
20% and 40% reduction of daily energy needs for weight maintenance



Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 4-6 weeks ]
    Insulin sensitivity index (i.e. Si) will be determined by using minimal modeling analysis of the IVGTT data.

  2. Beta-cell function [ Time Frame: 4-6 weeks ]
    Beta-cell function will be determined as the disposition index (i.e. product of acute insulin response [AIR] and Si) using minimal modeling analysis of the IVGTT data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females
  • Age between 21-65 years
  • BMI from ≥18 to <30 kg/m2 (BMI is equal to body weight in kilograms divided by height in metres squared)

Exclusion Criteria:

  • Persons with metabolic diseases that require use of medications (e.g. diabetes, heart disease, hypertension, etc.)
  • Persons using tobacco products (smokes daily or occasionally)
  • Persons who regularly consume alcohol (≥1 drink/day)
  • Women on oral contraceptives or hormone replacement therapy
  • Pregnant or breastfeeding women
  • Persons who have had recent weight loss or gain (≥5% over the past 6 months)
  • Persons with contraindication to calorie restriction (e.g. anemia) or exercise (e.g. asthma)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264001


Locations
Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117609
Sponsors and Collaborators
Clinical Nutrition Research Centre, Singapore
Investigators
Principal Investigator: Faidon Magkos, PhD Clinical Nutrition Research Centre

Publications:
Magkos, F. and L.S. Sidossis, Exercise and insulin sensitivity. Where do we stand? You'd better run! European Endocrinology, 2008. 4(1): p. 22-25.

Responsible Party: Faidon Magkos, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03264001     History of Changes
Other Study ID Numbers: NEB
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypersensitivity
Insulin Resistance
Glucose Intolerance
Protein-Energy Malnutrition
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Protein Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs