RecruitingPhase 2

The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether eating fewer calories helps glucagon, a hormone, work better in the liver. It looks at how the liver handles protein building blocks, sugars, and fats in people with type 2 diabetes.

Caloric restriction (and RYGB) improves insulin action and lowers fasting glucose, glucagon and EGP, without changes in postprandial EGP and glucagon concentrations. Caloric restriction also improves hepatic steatosis and lowers fasting AA. These changes may represent restoration of glucagon's hepatic actions. This experiment will determine whether caloric restriction improves glucagon's actions on hepatic amino acid, carbohydrate and lipid metabolism in T2DM in comparison to a baseline experiment performed separately in people with T2DM.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 2 diabetes and a stable weight.
  • Have a body mass index (BMI) of 28 or higher. BMI is a measure of weight compared with height.
  • Manage diabetes with diet alone or a combination of medicines taken by mouth.

Who can't join

  • Have had surgery in the upper belly, such as stomach banding or surgery on stomach nerves or the stomach outlet.
  • Have an active illness affecting the body as a whole, or cancer.
  • Have disease of large or small blood vessels that causes symptoms.
  • Cannot have an MRI scan, for example because of metal implants or fear of closed spaces.
  • Have a hematocrit below 35%. This means less than 35% of your blood is made up of red blood cells.
  • Have a TSH level below 0.4 or above 5.5. TSH is a hormone related to thyroid function.
  • Drink more than 2 alcoholic drinks a day or more than 14 a week, or have a positive result on the AUDIT alcohol-use screening questionnaire.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * We will recruit up to 20 weight-stable, subjects with type 2 diabetes * BMI ≥ 28 Kg/M2 * Diabetes is managed by diet alone or a combination of oral agents Exclusion Criteria: * History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g. metal implants, claustrophobia). * Hematocrit \< 35% * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire.

Study sites (1)

MN